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| Drug | Drug Trade Name | Approved Use | Manufacturer/Distributor | Approval Date |
|---|---|---|---|---|
| abarelix | Plenaxis depot | For the palliative treatment of men with advanced symptomatic prostate cancer, in whom LHRH agonist therapy is not appropriate and who refuse surgical castration, and have one or more of the following: (1) risk of neurological compromise due to metastases, (2) ureteral or bladder outlet obstruction due to local encroachment or metastatic disease, or (3) severe bone pain from skeletal metastases persisting on narcotic analgesia | Praecis | Nov 25 2003 |
| aldesleukin | Prokine | Treatment of adults with metastatic melanoma | Chiron | Jan 09 1998 |
| Aldesleukin | Proleukin | Treatment of adults with metastatic renal cell carcinoma | Chiron Corp | May 05 1992 |
| Alemtuzumab | Campath | Accel. Approv. (clinical benefit not established) Campath is indicated for the treatment of B-cell chronic lymphocytic leukemia (B-CLL) in patients who have been treated with alkylating agents and who have failed fludarabine therapy. | Millennium and ILEX Partners, LP | May 07 2001 |
| alitretinoin | Panretin | Topical treatment of cutaneous lesions in patients with AIDS-related Kaposi's sarcoma. | Ligand Pharmaceuticals | Feb 02 1999 |
| allopurinol | Zyloprim | Patients with leukemia, lymphoma and solid tumor malignancies who are receiving cancer therapy which causes elevations of serum and urinary uric acid levels and who cannot tolerate oral therapy. | GlaxoSmithKline | May 17 1996 |
| altretamine | Hexalen | Single agent palliative treatment of patients with persistent or recurrent ovarian cancer following first-line therapy with a cisplatin and/or alkylating agent based combination. | US Bioscience | Dec 26 1990 |
| amifostine | Ethyol | To reduce the cumulative renal toxicity associated with repeated administration of cisplatin in patients with advanced ovarian cancer | US Bioscience | Dec 08 1995 |
| amifostine | Ethyol | Accel. Approv. (clinical benefit not established) Reduction of platinum toxicity in non-small cell lung cancer | US Bioscience | Mar 15 1996 |
| amifostine | Ethyol | To reduce post-radiation xerostomia for head and neck cancer where the radiation port includes a substantial portion of the parotid glands. | US Bioscience | Jun 24 1999 |
| anakinra | Kineret | pediatric Use section of the US product label and to fulfill PMC #3 to assess the safety and efficacy of anakinra in pediatric patients with juvenile rheumatoid arthritis | Amgen | Dec 15 2006 |
| anastrozole | Arimidex | Accel. Approv. (clinical benefit not established) for the adjuvant treatment of postmenopausal women with hormone receptor positive early breast cancer | AstraZeneca | Sep 05 2002 |
| anastrozole | Arimidex | Conversion to regular approval for the adjuvant treatment of postmenopausal women with hormone receptor positive early breast cancer | AstraZeneca | Sep 16 2005 |
| anastrozole | Arimidex | Treatment of advanced breast cancer in postmenopausal women with disease progression following tamoxifen therapy. | AstraZeneca Pharmaceuticals | Dec 27 1995 |
| anastrozole | Arimidex | For first-line treatment of postmenopausal women with hormone receptor positive or hormone receptor unknown locally advanced or metastatic breast cancer. | AstraZeneca Pharmaceuticals | Sep 01 2000 |
| arsenic trioxide | Trisenox | Second line treatment of relapsed or refractory APL following ATRA plus an anthracycline. | Cell Therapeutic | Sep 25 2000 |
| asparaginase | Elspar | Therapy of patients with acute lymphocytic leukemia | Merck | Jan 10 1978 |
| Asparaginase | Elspar | ELSPAR is indicated in the therapy of patients with acute lymphocytic leukemia. This agent is useful primarily in combination with other chemotherapeutic agents in the induction of remissions of the disease in pediatric patients. | Merck & Co, Inc | Aug 01 2002 |
| azacitidine | Vidaza | For use for the treatment of patients with the following myelodysplastic syndrome subtypes: refractory anemia or refractory anemia with ringed sideroblasts (if accompanied by neutropenia or thrombocytopenia and requiring transfusions), refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia | Pharmion | May 19 2004 |
| azacitidine | Vidaza | indicated for treatment of patients with the following myelodysplastic syndrome subtypes: refractory anemia or refractory anemia with ringed sideroblasts (if accompanied by neutropenia or thrombocytopenia or requiring transfusions), refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia. | Pharmion | Jan 26 2007 |
| BCG Live | TICE BCG | Organon Teknika Corp | Aug 21 1998 | |
| bevacizumab | Avastin | Metastatic colon carcinoma | Genentech | Jun 20 2006 |
| bevacizumab | Avastin | FDA approved changed in the Avastin package insert regarding warning and dose and administration for Reversible Posterior Leukoencephalopathy Syndrome. Nasal septum perforation was also added as a serious adverse event. | Genentech | Sep 21 2006 |
| bevacizumab | Avastin | a first-line treatment of patients with locally advanced, metastatic or recurrent non-small cell lung cancer in combination with platinum-based chemotherapy | Genentech | Oct 11 2006 |
| bevacuzimab | Avastin | First-line treatment of patients with metastatic carcinoma of the colon and rectum (in combination with intravenous 5-fluorouracil-based chemotherapy) | Genentech | Feb 26 2004 |
| bexarotene capsules | Targretin | For the treatment by oral capsule of cutaneous manifestations of cutaneous T-cell lymphoma in patients who are refractory to at least one prior systemic therapy. | Ligand Pharmaceuticals | Dec 29 1999 |
| bexarotene gel | Targretin | For the topical treatment of cutaneous manifestations of cutaneous T-cell lymphoma in patients who are refractory to at least one prior systemic therapy. | Ligand Pharmaceuticals | Jun 28 2000 |
| bleomycin | Blenoxane | Bristol-Myers Squibb | Jul 31 1973 | |
| bleomycin | Blenoxane | Sclerosing agent for the treatment of malignant pleural effusion (MPE) and prevention of recurrent pleural effusions. | Bristol-Myers Squibb | Feb 20 1996 |
| bortezombi | Velcade | for the treatment of patients with mantle cell lymphoma who have received at least one prior therapy | Millennium | Dec 08 2006 |
| bortezomib | Velcade | Accel. Approv. (clinical benefit not established) for the treatment of multiple myeloma patients who have received at least two prior therapies and have demonstrated disease progression on the last therapy | Millenium | May 13 2003 |
| bortezomib | Velcade | Conversion to regular approval for treatment of multiple myeloma patients who have received as least one prior therapy | Millenium | Mar 25 2005 |
| busulfan intravenous | Busulfex | Use in combination with cyclophoshamide as conditioning regimen prior to allogeneic hematopoietic progenitor cell transplantation for chronic myelogenous leukemia. | Orphan Medical, Inc | Feb 04 1999 |
| busulfan oral | Myleran | Chronic Myelogenous Leukemia- palliative therapy | GlaxoSmithKline | Jun 26 1954 |
| calusterone | Methosarb | Pharmacia & Upjohn Company | Feb 20 1973 | |
| capecitabine | Xeloda | Accel. Approv. (clinical benefit subsequently established) Treatment of metastatic breast cancer resistant to both paclitaxel and an anthracycline containing chemotherapy regimen or resistant to paclitaxel and for whom further anthracycline therapy may be contraindicated, e.g., patients who have received cumulative doses of 400 mg/m2 of doxorubicin or doxorubicin equivalents | Roche | Apr 30 1998 |
| capecitabine | Xeloda | Initial therapy of patients with metastatic colorectal carcinoma when treatment with fluoropyrimidine therapy alone is preferred. Combination chemotherapy has shown a survival benefit compared to 5-FU/LV alone. A survival benefit over 5_FU/LV has not been demonstrated with Xeloda monotherapy. | Roche | Apr 30 2001 |
| capecitabine | Xeloda | Conversion to regular approval for treatment in combination with docetaxel of patients with metastatic breast cancer after failure of prior anthracycline containing chemotherapy | Roche | Sep 07 2001 |
| capecitabine | Xeloda | Adjuvant treatment in patients with Dukes’ C colon cancer who have undergone complete resection of the primary tumor when treatment with fluoropyrimidine therapy alone is preferred | Roche | Jun 15 2005 |
| carboplatin | Paraplatin | Palliative treatment of patients with ovarian carcinoma recurrent after prior chemotherapy, including patients who have been previously treated with cisplatin. | Bristol-Myers Squibb | Mar 03 1989 |
| carboplatin | Paraplatin | Initial chemotherapy of advanced ovarian carcinoma in combination with other approved chemotherapeutic agents. | Bristol-Myers Squibb | Jul 05 1991 |
| carmustine | BCNU, BiCNU | Bristol-Myers Squibb | Mar 07 1977 | |
| carmustine | Gliadel | Treatment of patients with malignant glioma undergoing primary surgical resection | MGI Pharma | Feb 25 2003 |
| carmustine with Polifeprosan 20 Implant | Gliadel Wafer | For use in addition to surgery to prolong survival in patients with recurrent glioblastoma multiforme who qualify for surgery. | Guilford Pharmaceuticals Inc. | Sep 23 1996 |
| celecoxib | Celebrex | Accel. Approv. (clinical benefit not established) Reduction of polyp number in patients with the rare genetic disorder of familial adenomatous polyposis. | Searle | Dec 23 1999 |
| cetuximab | Erbitux | Accel. Approv. (clinical benefit not established) for treatment of EGFR-expressing metastatic colorectal carcinoma in patients who are refractory to irinotecan-based chemotherapy (in combination with irinotecan); as a single agent, treatment of EGFR-expressing metastatic colorectal carcinoma in patients who are intolerant to irinotecan-based chemotherapy | Imclone | Feb 12 2004 |
| cetuximab | Erbitux | For use in combination with radiation therapy (RT) for the treatment of locally or regionally advanced squamous cell carcinoma of the head and neck (SCCHN) or as a single agent for the treatment of patients with recurrent or metastatic SCCHN for whom prior platinum-based therapy has failed. | Imclone | Mar 01 2006 |
| chlorambucil | Leukeran | GlaxoSmithKline | Mar 18 1957 | |
| cisplatin | Platinol | Metastatic testicular-in established combination therapy with other approved chemotherapeutic agents in patients with metastatic testicular tumors whoc have already received appropriate surgical and/or radiotherapeutic procedures. An established combination therapy consists of Platinol, Blenoxane and Velbam. | Bristol-Myers Squibb | Dec 19 1978 |
| cisplatin | Platinol | Metastatic ovarian tumors - in established combination therapy with other approved chemotherapeutic agents: Ovarian-in established combination therapy with other approved chemotherapeutic agents in patients with metastatic ovarian tumors who have already received appropriate surgical and/or radiotherapeutic procedures. An established combination consists of Platinol and Adriamycin. Platinol, as a single agent, is indicated as secondary therapy in patients with metastatic ovarian tumors refractory to standard chemotherapy who have not previously received Platinol therapy. | Bristol-Myers Squibb | Dec 19 1978 |
| cisplatin | Platinol | as a single agent for patients with transitional cell bladder cancer which is no longer amenable to local treatments such as surgery and/or radiotherapy. | Bristol-Myers Squibb | Apr 22 1993 |
| cladribine | Leustatin, 2-CdA | Treatment of active hairy cell leukemia. | R.W. Johnson Pharmaceutical Research Institute | Feb 26 1993 |
| clofarabine | Clolar | Accel. Approv. (clinical benefit not established) for the treatment of pediatric patients 1 to 21 years old with relapsed or refractory acute lymphoblastic leukemia after at least two prior regimens | Genzyme | Dec 28 2004 |
| cyclophosphamide | Cytoxan, Neosar | Bristol-Myers Squibb | Nov 16 1959 | |
| cyclophosphamide | Cytoxan Injection | Bristol-Myers Squibb | Nov 16 1959 | |
| cyclophosphamide | Cytoxan Injection | Bristol-Myers Squibb | Apr 29 1987 | |
| cyclophosphamide | Cytoxan Tablet | Bristol-Myers Squibb | Apr 29 1987 | |
| cytarabine | Cytosar-U | Pharmacia & Upjohn Company | Jun 17 1969 | |
| cytarabine liposomal | DepoCyt | Accel. Approv. (clinical benefit not established) Intrathecal therapy of lymphomatous meningitis | Skye Pharmaceuticals | Apr 01 1999 |
| dacarbazine | DTIC-Dome | Bayer | May 27 1975 | |
| dactinomycin, actinomycin D | Cosmegen | Merck | Feb 04 1964 | |
| dactinomycin, actinomycin D | Cosmegan | Merck | Dec 10 1964 | |
| dalteparin sodium | Fragmin | provides for the use of Fragmin (dalteparin sodium injection) for extended treatment of symptomatic venous thromboembolism (VTE) [proximal deep vein thrombosis (DVT) and/or pulmonary embolism (PE)] to reduce the recurrence of VTE in patients with cancer. | Pharmacia & Upjohn | May 01 2007 |
| darbepoetin alfa | Aranesp | for the treatment of anemia associated with chronic renal failure, including patients on dialysis and patients not on dialysis, and for the treatment of anemia in patients with non-myeloid malignancies where anemia is due to the effect of concomitantly administered chemotherapy. | Amgen | Mar 09 2007 |
| darbepoetin alfa | Aranesp | Amgen | Apr 10 2007 | |
| Darbepoetin alfa | Aranesp | Treatment of anemia associated with chronic renal failure. | Amgen, Inc | Sep 17 2001 |
| Darbepoetin alfa | Aranesp | Aranesp is indicated for the treatment of anemia in patients with non- myeloid malignancies where anemia is due to the effect of concomitantly administered chemotherapy. | Amgen, Inc | Jul 19 2002 |
| dasatinib | Sprycel | Chronic myelogenous leukemia | Bristol Myers Squibb | Jun 28 2006 |
| daunorubicin liposomal | DanuoXome | First line cytotoxic therapy for advanced, HIV related Kaposi's sarcoma. | Nexstar, Inc. | Apr 08 1996 |
| daunorubicin, daunomycin | Daunorubicin | Leukemia/myelogenous/monocytic/erythroid of adults/remission induction in acute lymphocytic leukemia of children and adults. | Bedford Labs | Jan 30 1998 |
| daunorubicin, daunomycin | Cerubidine | In combination with approved anticancer drugs for induction of remission in adult ALL. | Wyeth Ayerst | Mar 11 1987 |
| decitabine | Dacogen | for the treatment of patients with myelodysplastic syndromes (MDS) including previously treated and untreated, de novo and secondary MDS of all French-American-British subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia) and intermediate-1, intermediate-2, and high-risk International Prognostic Scoring System groups. | MGI PHARMA INC | May 05 2006 |
| denileukin | Ontak | Seragen | ||
| Denileukin diftitox | Ontak | Accel. Approv. (clinical benefit not established) treatment of patients with persistent or recurrent cutaneous T-cell lymphoma whose malignant cells express the CD25 component of the IL-2 receptor | Seragen, Inc | Feb 05 1999 |
| dexrazoxane | Zinecard | Accel. Approv. (clinical benefit subsequently established) Prevention of cardiomyopathy associated with doxorubicin administration | Pharmacia & Upjohn Company | May 26 1995 |
| dexrazoxane | Zinecard | Conversion to regular approval for reducing the incidence and severity of cardiomyopathy associated with doxorubicin administration in women with metastatic breast cancer who have received a cumulative doxorubicin dose of 300 mg/m2 and who will continue to receive doxorubicin therapy to maintain tumor control. It is not recommended for use with the initiation of doxorubicin therapy. | Pharmacia & Upjohn Company | Oct 31 2002 |
| docetaxel | Taxotere | Accel. Approv. (clinical benefit subsequently established) Treatment of patients with locally advanced or metastatic breast cancer who have progressed during anthracycline-based therapy or have relapsed during anthracycline-based adjuvant therapy. | Aventis Pharmaceutical | May 14 1996 |
| docetaxel | Taxotere | Conversion to regular approval - treatment of locally advanced or metastatic breast cancer which has progressed during anthracycline-based treatment or relapsed during anthracycline-based adjuvant therapy. | Aventis Pharmaceutical | Jun 22 1998 |
| docetaxel | Taxotere | For locally advanced or metastatic non-small cell lung cancer after failure of prior platinum-based chemotherapy. | Aventis Pharmaceutical | Dec 23 1999 |
| docetaxel | Taxotere | for use in combination with cisplatin for the treatment of patients with unresectable, locally advanced or metastatic non-small cell lung cancer who have not previously received chemotherapy for this condition cisplatin for the treatment of patients with unresectable, locally advanced or metastatic non-small cell lung cancer who have not previously received chemotherapy for this condition. | Aventis Pharmaceutical | Nov 27 2002 |
| docetaxel | Taxotere | For use in combination with prednisone as a treatment for patients with androgen independent (hormone refractory) metastatic prostate cancer | Aventis Pharmaceutical | May 19 2004 |
| docetaxel | Taxotere | For use in combination with doxorubicin and cyclophosphamide for the adjuvant treatment of patients with operable nodepositive breast cancer | Aventis Pharmaceutical | Aug 18 2004 |
| docetaxel | Taxotere | for use in combination with cisplatin and fluorouracil for the induction treatment of patients with inoperable, locally advanced squamous cell carcinoma of the head and neck. | Sanofi Aventis | Oct 17 2006 |
| doxorubicin | Adriamycin PFS | For use in combination with cyclophosphamide as a component of adjuvant therapy in patients with evidence of axillary node tumor involvement following resection of primary breast cancer | Pharmacia | May 08 2003 |
| doxorubicin | Adriamycin, Rubex | Pharmacia & Upjohn Company | Aug 07 1974 | |
| doxorubicin | Adriamycin PFS Injectionintravenous injection | Antibiotic, antitumor agent. | Pharmacia & Upjohn Company | Dec 23 1987 |
| doxorubicin liposomal | Doxil | Conversion to regular approval for treatment of patients with ovarian cancer whose disease has progressed or recurred after platinum-based chemotherapy | Alza | Jan 28 2005 |
| doxorubicin liposomal | Doxil | Accel. Approv. (clinical benefit not established) Treatment of AIDS-related Kaposi's sarcoma in patients with disease that has progressed on prior combination chemotherapy or in patients who are intolerant to such therapy. | Sequus Pharmaceuticals, Inc. | Nov 17 1995 |
| doxorubicin liposomal | Doxil | Accel. Approv. (clinical benefit not established) Treatment of metastatic carcinoma of the ovary in patient with disease that is refractory to both paclitaxel and platinum based regimens | Sequus Pharmaceuticals, Inc. | Jun 28 1999 |
| DROMOSTANOLONE PROPIONATE | DROMOSTANOLONE | Eli Lilly | Oct 26 1961 | |
| DROMOSTANOLONE PROPIONATE | MASTERONE INJECTION | SYNTEX | Oct 08 1964 | |
| eculizumab | Soliris | for the treatment of paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis. | Alexion | Mar 16 2007 |
| Elliott's B Solution | Elliott's B Solution | Diluent for the intrathecal administration of methotrexate sodium and cytarabine for the prevention or treatment of meningeal leukemia or lymphocytic lymphoma. | Orphan Medical, Inc | Sep 27 1996 |
| epirubicin | Ellence | A component of adjuvant therapy in patients with evidence of axillary node tumor involvement following resection of primary breast cancer. | Pharmacia & Upjohn Company | Sep 15 1999 |
| epirubicin hcl | epirubicin hcl | as a component of adjuvant therapy in patients with evidence of axillary node tumor involvement following resection of primary breast cancer. | Mayne | Sep 15 2006 |
| epoetin alfa | Epogen/Procrit | is indicated for the treatment of anemia related to therapy with zidovudine in HIV-infected patients. EPOGEN® is indicated to elevate or maintain the red blood cell level (as manifested by the hematocrit or hemoglobin determinations) and to decrease the need for transfusions in these patients. EPOGEN® is not indicated for the treatment of anemia in HIV-infected patients due to other factors such as iron or folate deficiencies, hemolysis, or gastrointestinal bleeding, which should be managed appropriately. | Amgen | Mar 09 2007 |
| Epoetin alfa | epogen | EPOGENB is indicated for the treatment of anemia in patients with non-myeloid malignancies where anemia is due to the effect of concomitantly administered chemotherapy. EPOGEND is indicated to decrease the need for transfusions in patients who will be receiving concomitant chemotherapy for a minimum of 2 months. EPOGENB is not indicated for the treatment of anemia in cancer patients due to other factors such as iron or folate deficiencies, hemolysis or gastrointestinal bleeding, which should be managed appropriately. | Amgen, Inc | Jul 26 1999 |
| Epoetin alfa | epogen | EPOGENB is indicated for the reatment of anemia related to therapy with zidovudine in HIV- infected patients. EPOGENB is indicated to elevate or maintain the red blood cell level (as manifested by the hematocrit or hemoglobin determinations) and to decrease the need for transfusions in these patients. EPOGEND is not indicated for the treatment of anemia in HIV-infected patients due to other factors such as iron or folate deficiencies, hemolysis or gastrointestinal bleeding, which should be managed appropriately. | Amgen, Inc | Jul 26 1999 |
| Epoetin alfa | epogen | EPOGENB is indicated for the treatment of anemic patients (hemoglobin > 10 to _< 13 g/dL) scheduled to undergo elective, noncardiac, nonvascular surgery to reduce the need for allogeneic blood transfusions. | Amgen, Inc | Jul 26 1999 |
| Epoetin alfa | epogen | EPOGEN is indicated for the treatment of anemia associated with CRF, including patients on dialysis (ESRD) and patients not on dialysis. | Amgen, Inch | Jul 26 1999 |
| erlotinib | Tarceva | For treatment of locally advanced or metastatic Non Small-Cell Lung Cancer (NSCLC) after failure of at least one prior chemotherapy regimen | OSI | Nov 18 2004 |
| erlotinib | Tarceva | For use in combination with gemcitabine for the first-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer | OSI | Nov 02 2005 |
| estramustine | Emcyt | palliation of prostate cancer | Pharmacia & Upjohn Company | Dec 24 1981 |
| etoposide phosphate | Etopophos | Management of refractory testicular tumors, in combination with other approved chemotherapeutic agents. | Bristol-Myers Squibb | May 17 1996 |
| etoposide phosphate | Etopophos | Management of small cell lung cancer, first-line, in combination with other approved chemotherapeutic agents. | Bristol-Myers Squibb | May 17 1996 |
| etoposide phosphate | Etopophos | Management of refractory testicular tumors and small cell lung cancer. | Bristol-Myers Squibb | Feb 27 1998 |
| etoposide, VP-16 | Vepesid | Refractory testicular tumors-in combination therapy with other approved chemotherapeutic agents in patients with refractory testicular tumors who have already received appropriate surgical, chemotherapeutic and radiotherapeutic therapy. | Bristol-Myers Squibb | Nov 10 1983 |
| etoposide, VP-16 | VePesid | In combination with other approved chemotherapeutic agents as first line treatment in patients with small cell lung cancer. | Bristol-Myers Squibb | Dec 30 1986 |
| etoposide, VP-16 | Vepesid | In combination with other approved chemotherapeutic agents as first line treatment in patients with small cell lung cancer. | Bristol-Myers Squibb | Dec 30 1986 |
| exemestane | Aromasin | For adjuvant treatment of postmenopausal women with estrogen-receptor positive early breast cancer who have received two to three years of tamoxifen and are switched to AROMASIN® for completion of a total of five consecutive years of adjuvant hormonal therapy | Pharmacia | Oct 05 2005 |
| exemestane | Aromasin | Treatment of advance breast cancer in postmenopausal women whose disease has progressed following tamoxifen therapy. | Pharmacia & Upjohn Company | Oct 21 1999 |
| fentanyl citrate | Fentora | for the management of breakthrough pain in patients with cancer who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain. | Cephalon | Sep 25 2006 |
| Filgrastim | Neupogen | Decrease incidence of infection in patients with nonmyeloid malignancies | Amgen, Inc | Feb 20 1991 |
| Filgrastim | Neupogen | NEUPOGEN is indicated to decrease the incidence of infection‚ as manifested by febrile neutropenia‚ in patients with nonmyeloid malignancies receiving myelosuppressive anticancer drugs associated with a significant incidence of severe neutropenia with fever. | Amgen, Inc | Apr 02 1998 |
| Filgrastim | Neupogen | NEUPOGEN is indicated for reducing the time to neutrophil recovery and the duration of fever, following induction or consolidation hemotherapy treatment of adults with AML. | Amgen, Inc | Apr 02 1998 |
| Filgrastim | Neupogen | NEUPOGEN is indicated to reduce the duration of neutropenia and neutropenia-related clinical sequelae, eg, febrile neutropenia, in patients with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by marrow transplantation. | Amgen, Inc | Apr 02 1998 |
| floxuridine (intraarterial) | FUDR | Roche | Dec 18 1970 | |
| fludarabine | Fludara | Palliative treatment of patients with B-cell lymphocytic leukemia (CLL) who have not responded or have progressed during treatment with at least one standard alkylating agent containing regimen. | Berlex Laboratories Inc. | Apr 18 1991 |
| fluorouracil, 5-FU | Adrucil | prolong survival in combination with leucovorin | ICN Puerto Rico | Apr 25 1962 |
| fulvestrant | Faslodex | the treatment of hormone receptor-positive metastatic breast cancer in postmenopausal women with disease progression following antiestrogen therapy | IPR | Apr 25 2002 |
| gefitinib | Iressa | Accel. Approv. (clinical benefit not established ) as monotherapy for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of both platinum-based and docetaxel chemotherapies | AstraZenca | May 05 2003 |
| gemcitabine | Gemzar | Treatment of patients with locally advanced (nonresectable stage II or III) or metastatic (stage IV) adenocarcinoma of the pancreas. Indicated for first-line treatment and for patients previously treated with a 5-fluorouracil-containing regimen. | Eli Lilly | May 15 1996 |
| gemcitabine | Gemzar | For use in combination with cisplatin for the first-line treatment of patients with inoperable, locally advanced (Stage IIIA or IIIB) or metastatic (Stage IV) non-small cell lung cancer. | Eli Lilly | Aug 25 1998 |
| gemcitabine hcl | Gemzar | Ovarian cancer | Lilly | Jul 14 2006 |
| gemicitabine | Gemzar | For use in combination with paclitaxel for the first-line treatment of patients with metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines were clinically contraindicated | Lilly | May 19 2004 |
| gemtuzumab ozogamicin | Mylotarg | Accel. Approv. (clinical benefit not established) Treatment of CD33 positive acute myeloid leukemia in patients in first relapse who are 60 years of age or older and who are not considered candidates for cytotoxic chemotherapy. | Wyeth Ayerst | May 17 2000 |
| goserelin acetate | Zoladex | AstraZeneca Pharmaceuticals | Dec 18 1995 | |
| goserelin acetate | Zoladex Implant | Palliative treatment of advanced breast cancer in pre- and perimenopausal women. | AstraZeneca Pharmaceuticals | Dec 18 1995 |
| histrelin acetate | Histrelin implant | For the palliative treatment of advanced prostate cancer | Valera | Oct 12 2004 |
| hydroxyurea | Hydrea | Bristol-Myers Squibb | Dec 07 1967 | |
| hydroxyurea | Hydrea | Decrease need for transfusions in sickle cell anemia | Bristol-Myers Squibb | Feb 25 1998 |
| Ibritumomab Tiuxetan | Zevalin | Accel. Approv. (clinical benefit not established) treatment of patients with relapsed or refractory low-grade, follicular, or transformed B-cell non-Hodgkin's lymphoma, including patients with Rituximab refractory follicular non-Hodgkin’s lymphoma. | IDEC Pharmaceuticals Corp | Feb 19 2002 |
| idarubicin | Idamycin | For use in combination with other approved antileukemic drugs for the treatment of acute myeloid leukemia (AML) in adults. | Adria Laboratories | Sep 27 1990 |
| idarubicin | Idamycin | In combination with other approved antileukemic drugs for the treatment of acute non-lymphocytic leukemia in adults. | Pharmacia & Upjohn Company | Feb 17 1997 |
| ifosfamide | IFEX | Third line chemotherapy of germ cell testicular cancer when used in combination with certain other approved antineoplastic agents. | Bristol-Myers Squibb | Dec 30 1988 |
| imatinib mesylate | Gleevec | Accel. Approv. (clinical benefit not established) Initial therapy of chronic myelogenous leukemia | Novartis | May 10 2001 |
| imatinib mesylate | Gleevec | Accel. Approv. (clinical benefit not established) metastatic or unresectable malignant gastrointestinal stromal tumors | Novartis | Feb 01 2002 |
| Imatinib mesylate | Gleevec | Accel. Approv. (clinical benefit not established) Treatment of patients with Kit (CD117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumors (GIST). | Novartis | Feb 01 2002 |
| imatinib mesylate | Gleevec | Accel. Approv. (clinical benefit not established) Initial treatment of newly diagnosed Ph+ chronic myelogenous leukemia (CML). | Novartis | Dec 20 2002 |
| imatinib mesylate | Gleevec | Accel. Approv. (clinical benefit not established) for treatment of newly diagnosed adult patients with Philadelphia chromosome positive chronic myeloid leukemia (CML) in chronic phase. Follow-up is limited. Gleevec is also indicated for the treatment of patients with Philadelphia chromosome positive chronic myeloid leukemia (CML) in blast crisis, accelerated phase, or in chronic phase after failure of interferon-alpha therapy. There are no controlled trials demonstrating a clinical benefit, such as improvement in disease-related symptoms or increased survival in patients with CML blast crisis, accelerated phase or chronic phase after failure of alpha interferon. Gleevec is also indicated for the treatment of patients with Kit (CD117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumors (GIST) | Novartis | Apr 18 2003 |
| imatinib mesylate | Gleevec | Accel. Approv. (clinical benefit not established) Treatment of pediatric patients with Ph+ chronic phase CML whose disease has recurred after stem cell transplant or who are resistant to interferon alpha therapy. | Novartis | May 20 2003 |
| imatinib mesylate | Gleevec | Conversion to regular approval for treatment of patients with Philadelphia chromosome positive chronic myeloid leukemia (CML) in blast crisis, accelerated phase, or in chronic phase after failure of interferon-alpha therapy | Novartis | Dec 08 2003 |
| imatinib mesylate | Gleevec | for the treatment of pediatric patients with newly diagnosed Philadelphia chromosome positive chronic myelogenous leukemia (Ph+ CML). | Novartis | Sep 27 2006 |
| imatinib mesylate | Gleevec | single agent for the treatment of multiple indications | Novartis | Oct 19 2006 |
| interferon alfa 2a | Roferon A | Treatment of patients with hairy cell leukemia | Roche | Jun 04 1986 |
| interferon alfa 2a | Roferon A | Chronic phase, Philadelphia chromosome positive chronic myelogenous leukemia (CML) patients who are minimally pretreated (within 1 year of diagnosis) | Roche | Oct 19 1995 |
| Interferon alfa-2a | Roferon-A | Hoffmann-La Roche Inc | Nov 01 1996 | |
| Interferon alfa-2b | Intron A | Interferon alfa-2b, recombinant for Injection is indicated for the treatment of patients 18 years of age or older with hairy cell leukemia. | Schering Corp | Jun 04 1986 |
| Interferon alfa-2b | Intron A | Interferon alfa-2b, recombinant for Injection is indicated for intralesional treatment of selected patients 18 years of age or older with condylomata acuminata involving external surfaces of the genital and perianal areas. | Schering Corp | Jun 06 1988 |
| Interferon alfa-2b | Intron A | Interferon alfa-2b, recombinant for injection is indicated for the treatment of selected patients 18 years of age or older with AIDS-related Kaposi's Sarcoma. The likelihood of response to INTRON A therapy is greater in patients who are without systemic symptoms, who have limited lymphadenopathy and who have a relatively intact immune system as indicated by total CD4 count. | Schering Corp | Nov 21 1988 |
| Interferon alfa-2b | Intron A | Interferon alfa-2b, recombinant for injection is indicated as adjuvant to surgical treatment in patients 18 years of age or older with malignant melanoma who are free of disease but at high risk for systemic recurrence within 56 days of surgery. | Schering Corp | Dec 05 1995 |
| Interferon alfa-2b | Intron A | Interferon alfa-2b, recombinant for Injection is indicated for the initial treatment of clinically aggressive follicular non-Hodgkin’s Lymphoma in conjunction with anthracycline-containing combination chemotherapy in patients 18 years of age or older. | Schering Corp | Nov 06 1997 |
| Interferon alfa-2b | Intron A Intron A | Schering Corp | Jun 21 2002 | |
| irinotecan | Camptosar | Accel. Approv. (clinical benefit subsequently established) Treatment of patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following 5-FU-based therapy. | Pharmacia & Upjohn Company | Jun 14 1996 |
| irinotecan | Camptosar | Conversion to regular approval - treatment of metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following 5-FU-based therapy. | Pharmacia & Upjohn Company | Oct 22 1998 |
| irinotecan | Camptosar | For first line treatment n combination with 5-FU/leucovorin of metastatic carcinoma of the colon or rectum. | Pharmacia & Upjohn Company | Apr 20 2000 |
| lapatinib ditosylate | Tykerb | for use in combination with capecitabine for the treatment of patients with advanced or metastatic breast cancer whose tumors overexpress HER2 (ErbB2) and who have received prior therapy including an anthracycline, a taxane, and trastuzumab. | SmithKline Beecham | Mar 13 2007 |
| lapatinib ditosylate | Tykerb | SmithKline Beecham | Apr 27 2007 | |
| lenalidomide | Revlimid | Multiple myeloma | Celegene | Jun 29 2006 |
| lenalidomide | Revlimid | for the treatment of patients with transfusion-dependent anemia due to Low- or Intermediate-1-risk myelodysplastic syndromes associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities | Celgene | Dec 27 2005 |
| letrozole | Femara | Treatment of advanced breast cancer in postmenopausal women. | Novartis | Jul 25 1997 |
| letrozole | Femara | First-line treatment of postmenopausal women with hormone receptor positive or hormone receptor unknown locally advanced or metastatic breast cancer. | Novartis | Jan 10 2001 |
| letrozole | Femara | Novartis | Jan 17 2003 | |
| letrozole | Femara | Accel. Approv. (clinical benefit not established) for the extended adjuvant treatment of early breast cancer in postmenopausal women who have received five years of adjuvant tamoxifen therapy. | Novartis | Oct 29 2004 |
| leucovorin | Wellcovorin, Leucovorin | Leucovorin calcium is indicated fro use in combination with 5-fluorouracil to prolong survival in the palliative treatment of patients with advanced colorectal cancer. | Immunex Corporation | Jun 20 1952 |
| leucovorin | Leucovorin | Immunex Corporation | Jan 30 1987 | |
| leucovorin | Leucovorin | Immunex Corporation | Jan 30 1987 | |
| leucovorin | Leucovorin | Immunex Corporation | Aug 31 1988 | |
| leucovorin | Leucovorin | In combination with fluorouracil to prolong survival in the palliative treatment of patients with advanced colorectal cancer. | Lederle Laboratories | Dec 12 1991 |
| Leuprolide Acetate | Eligard | palliative treatment of advanced prostate cancer. | QLT USA | Jan 23 2002 |
| levamisole | Ergamisol | Adjuvant treatment in combination with 5-fluorouracil after surgical resection in patients with Dukes' Stage C colon cancer. | Janssen Research Foundation | Jun 18 1990 |
| lomustine, CCNU | CeeBU | Bristol-Myers Squibb | Aug 04 1976 | |
| meclorethamine, nitrogen mustard | Mustargen | Merck | Mar 15 1949 | |
| megestrol acetate | Megace | Bristol-Myers Squibb | Aug 18 1971 | |
| melphalan, L-PAM | Alkeran | GlaxoSmithKline | Jan 17 1964 | |
| melphalan, L-PAM | Alkeran | Systemic administration for palliative treatment of patients with multiple myeloma for whom oral therapy is not appropriate. | GlaxoSmithKline | Nov 18 1992 |
| mercaptopurine, 6-MP | Purinethol | GlaxoSmithKline | Sep 11 1953 | |
| mesna | Mesnex | Prevention of ifosfamide-induced hemorrhagic cystitis | Asta Medica | Dec 30 1988 |
| mesna | Mesnex tabs | Reducing the incidence of ifosfamide-induced hemorrhagic cystitis | Baxter | Mar 21 2002 |
| methotrexate | Methotrexate | Lederle Laboratories | Dec 07 1953 | |
| methotrexate | Methotrexate | Lederle Laboratories | Aug 10 1959 | |
| methotrexate | Methotrexate | Lederle Laboratories | Nov 01 1971 | |
| methotrexate | Methotrexate | Lederle Laboratories | Nov 01 1971 | |
| methotrexate | Methotrexate | osteosarcoma | Lederle Laboratories | Apr 07 1988 |
| methotrexate | Methotrexate | Lederle Laboratories | Oct 31 1988 | |
| methoxsalen | Uvadex | For the use of UVADEX with the UVAR Photopheresis System in the palliative treatment of the skin manifestations of cutaneous T-cell lymphoma (CTCL) that is unresponsive to other forms of treatment. | Therakos | Feb 25 1999 |
| mitomycin C | Mutamycin | Bristol-Myers Squibb | May 28 1974 | |
| mitomycin C | Mitozytrex | therapy of disseminated adenocarcinoma of the stomach or pancreas in proven combinations with other approved chemotherapeutic agents and as palliative treatment when other modalities have failed. | Supergen | Nov 14 2002 |
| mitotane | Lysodren | Bristol-Myers Squibb | Jul 08 1970 | |
| mitoxantrone | Novantrone | For use in combination with corticosteroids as initial chemotherapy for the treatment of patients with pain related to advanced hormone-refractory prostate cancer. | Immunex Corporation | Nov 13 1996 |
| mitoxantrone | Novantrone | For use with other approved drugs in the initial therapy for acute nonlymphocytic leukemia (ANLL) in adults. | Lederle Laboratories | Dec 23 1987 |
| nandrolone phenpropionate | Durabolin-50 | Organon | Oct 30 1959 | |
| nelarabine | Arranon | Accel. Approv. (clinical benefit not established) for the treatment of patients with T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma whose disease has not responded to or has relapsed following treatment with at least two chemotherapy regimens | GlaxoSmithKline | Oct 28 2005 |
| Nofetumomab | Verluma | Boehringer Ingelheim Pharma KG (formerly Dr. Karl Thomae GmbH) | Aug 20 1996 | |
| Oprelvekin | Neumega | Prevention of severe thrombocytopenia following myelosuppressive chemotherapy | Genetics Institute, Inc | Nov 25 1997 |
| Oprelvekin | Neumega | Genetics Institute, Inc | Sep 18 2002 | |
| Oprelvekin | Neumega | Neumega is indicated for the prevention of severe thrombocytopenia and the reduction of the need for platelet transfusions following myelosuppressive chemotherapy in adult patients with nonmyeloid malignancies who are at high risk of severe thrombocytopenia. | Genetics Institute, Inc | Sep 18 2002 |
| oprelvekin | Neumega | warnings regarding ophthalmologic and ventricular arrhythmias adverse events have been added to the oprelvekin (Neumega) label | Wyeth | Sep 13 2006 |
| oxaliplatin | Eloxatin | Accel. Approv. (clinical benefit not established) in combination with infusional 5-FU/LV, is indicated for the treatment of patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed during or within 6 months of completion of first line therapy with the combination of bolus 5-FU/LV and irinotecan. | Sanofi Synthelabo | Aug 09 2002 |
| oxaliplatin | Eloxatin | Conversion to regular approval for use in combination with infusional 5-Fluorouracil (5-FU) and Leucovorin (LV) for the treatment of patients previously untreated for advanced colorectal cancer | Sanofi Synthelabo | Jan 09 2004 |
| oxaliplatin | Eloxatin | for use in combination with infusional 5-FU/LV, for the adjuvant treatment of stage III colon cancer patients who have undergone complete resection of the primary tumor | Sanofi Synthelabo | Nov 04 2004 |
| paclitaxel | Abraxane | for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated. | Abraxis | Feb 15 2007 |
| paclitaxel | Paxene | treatment of advanced AIDS-related Kaposi's sarcoma after failure of first line or subsequent systemic chemotherapy | Baker Norton Pharmaceuticals, Inc | Dec 24 1997 |
| paclitaxel | Taxol | Treatment of patients with metastatic carcinoma of the ovary after failure of first-line or subsequent chemotherapy. | Bristol-Myers Squibb | Dec 29 1992 |
| paclitaxel | Taxol | Treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated. | Bristol-Myers Squibb | Apr 13 1994 |
| paclitaxel | Taxol | New dosing regimen for patients who have failed initial or subsequent chemotherapy for metastatic carcinoma of the ovary | Bristol-Myers Squibb | Jun 22 1994 |
| paclitaxel | Taxol | second line therapy for AIDS related Kaposi's sarcoma. | Bristol-Myers Squibb | Aug 04 1997 |
| paclitaxel | Taxol | For first-line therapy for the treatment of advanced carcinoma of the ovary in combination with cisplatin. | Bristol-Myers Squibb | Apr 09 1998 |
| paclitaxel | Taxol | for use in combination with cisplatin, for the first-line treatment of non-small cell lung cancer in patients who are not candidates for potentially curative surgery and/or radiation therapy. | Bristol-Myers Squibb | Jun 30 1998 |
| paclitaxel | Taxol | For the adjuvant treatment of node-positive breast cancer administered sequentially to standard doxorubicin-containing combination therapy. | Bristol-Myers Squibb | Oct 25 1999 |
| paclitaxel | Taxol | First line ovarian cancer with 3 hour infusion. | Bristol-Myers Squibb | Jun 20 2000 |
| paclitaxel protein-bound particles | Abraxane | For the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracyline unless clinically contraindicated | AM Bioscience | Jan 07 2005 |
| palifermin | Kepivance | Decrease the incidence and duration of severe oral mucositis in patients with hematologic malignancies receiving myelotoxic therapy requiring hematopoetic stem cell support | Amgen | Dec 15 2004 |
| pamidronate | Aredia | Treatment of osteolytic bone metastases of breast cancer in conjunction with standard antineoplastic therapy. | Novartis | Sep 22 1998 |
| panitumumab | Vectibix | to treat metastatic colorectal carcinoma | Amgen | Sep 27 2006 |
| pegademase | Adagen (Pegademase Bovine) | Enzyme replacement therapy for patients with severe combined immunodeficiency asa result of adenosine deaminase deficiency. | Enzon | Mar 21 1990 |
| pegaspargase | Oncaspar | Acute lymphoblastic leukemia | Enzon | Jul 24 2006 |
| pegaspargase | Oncaspar | Acute lymphocytic leukemia in L-asparaginase hypersensitive patients | Enzon, Inc | Feb 01 1994 |
| Pegfilgrastim | Neulasta | Neulasta is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. | Amgen, Inc | Jan 31 2002 |
| Peginterferon alfa-2b | PegIntron | trade name from PEG-Intron to PegIntron | Schering | Dec 22 2006 |
| pemetrexed disodium | Alimta | For use in the treatment of patients with malignant pleural mesothelioma whose disease is either unresectable or who are otherwise not candidates for curative surgery | Lilly | Feb 04 2004 |
| pemetrexed disodium | Alimta | Accel. Approv. (clinical benefit not established) as a single agent for the treatment of patients with locally advanced or metastatic non-small lung cancer after prior chemotherapy | Lilly | Aug 19 2004 |
| pentostatin | Nipent | Single agent treatment for adult patients with alpha interferon refractory hairy cell leukemia. | Parke-Davis Pharmaceutical Co. | Oct 11 1991 |
| pentostatin | Nipent | Single-agent treatment for untreated hairy cell leukemia patients with active disease as defined by clinically significant anemia, neutropenia, thrombocytopenia, or disease-related symptoms. (Supplement for front -line therapy.) | Parke-Davis Pharmaceutical Co. | Sep 29 1993 |
| pipobroman | Vercyte | Abbott Labs | Jul 01 1966 | |
| plicamycin, mithramycin | Mithracin | Pfizer Labs | May 05 1970 | |
| porfimer sodium | Photofrin | For the ablation of high-grade dysplasia in Barrett’s esophagus patients who do not undergo esophagectomy | Axcan Scandipharm | Aug 01 2003 |
| porfimer sodium | Photofrin | For use in photodynamic therapy (PDT) for palliation of patients with completely obstructing esophageal cancer, or patients with partially obstructing esophageal cancer who cannot be satisfactorily treated with ND-YAG laser therapy. | QLT Phototherapeutics Inc. | Dec 27 1995 |
| porfimer sodium | Photofrin | For use in photodynamic therapy for treatment of microinvasive endobronchial nonsmall cell lung cancer in patients for whom surgery and radiotherapy are not indicated. | QLT Phototherapeutics Inc. | Jan 09 1998 |
| porfimer sodium | Photofrin | For use in photodynamic therapy (PDT) for reduction of obstruction and palliation of symptoms in patients with completely or partially obstructing endobroncial nonsmall cell lung cancer (NSCLC). | QLT Phototherapeutics Inc. | Dec 22 1998 |
| procarbazine | Matulane | Sigma Tau Pharms | Jul 22 1969 | |
| quinacrine | Atabrine | Abbott Labs | Dec 07 1964 | |
| Rasburicase | Elitek | ELITEK is indicated for the initial management of plasma uric acid levels in pediatric patients with leukemia, lymphoma, and solid tumor malignancies who are receiving anti-cancer therapy expected to result in tumor lysis and subsequent elevation of plasma uric acid. | Sanofi-Synthelabo, Inc | Jul 12 2002 |
| rituximab | Rituxan | for the first-line treatment of patients with low grade or follicular, CD20-positive B-cell non-Hodgkin’s lymphoma. | Genentech | Sep 29 2006 |
| rituximab | Rituxan | for the first-line treatment of patients with low grade or follicular, CD20-positive B-cell non-Hodgkin’s lymphoma. | Genentech | Sep 29 2006 |
| Rituximab | Rituxan | Treatment of patients with relapsed or refractory low-grade or follicular B-cell non-Hodgkin's lymphoma | Genentech, Inc | Nov 26 1997 |
| Rituximab | Rituxan | non-Hodgkin's lymphoma | Genentech, Inc | Feb 10 2006 |
| sargramostim | Leukine | Acceleration of myeloid recovery following autologous bone marrow transplant in patients with non-Hodgkin's lymphoma, acute lymphocytic leukemia, or Hodgkin's disease | Berlex | Mar 05 1991 |
| Sargramostim | Prokine | Immunex Corp | Nov 07 1996 | |
| sorafenib | Nexavar | For the treatment of patients with advanced renal cell carcinoma | Bayer | Dec 20 2005 |
| streptozocin | Zanosar | Antineoplastic agent. | Pharmacia & Upjohn Company | May 07 1982 |
| sunitinib | Sutent | for the treatment of gastrointestinal stromal tumor after disease progression on or intolerance to imatinib mesylate; for the treatment of advanced renal cell carcinoma. | CP Pharmaceuticals | Feb 02 2007 |
| sunitinib maleate | Sutent | treatment of gastrointestinal stromal tumor after disease progression on or intolerance to imatinib mesylate | Pfizer | Jan 26 2006 |
| sunitinib maleate | Sutent | Accel. Approv. (clinical benefit not established) for the treatment of advanced renal cell carcinoma. Approval for advanced renal cell carcinoma is based on partial response rates and duration of responses. There are no randomized trials of SUTENT demonstrating clinical benefit such as increased survival or improvement in disease-related symptoms in renal cell carcinoma. | Pfizer | Jan 26 2006 |
| talc | Sclerosol | For the prevention of the recurrence of malignant pleural effusion in symptomatic patients. | Bryan | Dec 24 1997 |
| tamoxifen | Nolvadex | AstraZeneca Pharmaceuticals | Dec 30 1977 | |
| tamoxifen | Nolvadex | As a single agent to delay breast cancer recurrence following total mastectomy and axillary dissection in postmenopausal women with breast cancer (T1-3, N1, M0) | AstraZeneca Pharmaceuticals | Dec 03 1986 |
| tamoxifen | Nolvadex | For use in premenopausal women with metastatic breast cancer as an alternative to oophorectomy or ovarian irradiation | AstraZeneca Pharmaceuticals | Mar 16 1989 |
| tamoxifen | Nolvadex | For use in women with axillary node-negative breast cancer adjuvant therapy. | AstraZeneca Pharmaceuticals | Jun 21 1990 |
| tamoxifen | Nolvadex | Metastatic breast cancer in men. | AstraZeneca Pharmaceuticals | Apr 01 1993 |
| tamoxifen | Nolvadex | Equal bioavailability of a 20 mg Nolvadex tablet taken once a day to a 10 mg Nolvadex tablet taken twice a day. | AstraZeneca Pharmaceuticals | Mar 21 1994 |
| tamoxifen | Nolvadex | to reduce the incidence of breast cancer in women at high risk for breast cancer | AstraZeneca Pharmaceuticals | Oct 29 1998 |
| tamoxifen | Nolvadex | In women with DCIS, following breast surgery and radiation, Nolvadex is indicated to reduce the risk of invasive breast cancer. | AstraZeneca Pharmaceuticals | Jun 29 2000 |
| temozolomide | Temodar | Accel. Approv. (clinical benefit not established) Treatment of adult patients with refractory anaplastic astrocytoma, i.e., patients at first relapse with disease progression on a nitrosourea and procarbazine containing regimen | Schering | Aug 11 1999 |
| temozolomide | Temodar | Conversion to regular approval for the treatment of patients with newly diagnosed high grade gliomas concomitantly with radiotherapy and then as adjuvant treatment | Schering | Mar 15 2005 |
| teniposide, VM-26 | Vumon | In combination with other approved anticancer agents for induction therapy in patients with refractory childhood acute lymphoblastic leukemia (all). | Bristol-Myers Squibb | Jul 14 1992 |
| testolactone | Teslac | Bristol-Myers Squibb | Jun 03 1969 | |
| testolactone | Teslac | Bristol-Myers Squibb | May 27 1970 | |
| thalidomide | Thalomid | Multiple myeloma | Celgene | May 26 2006 |
| thioguanine, 6-TG | Thioguanine | GlaxoSmithKline | Jan 18 1966 | |
| thiotepa | Thioplex | Immunex Corporation | Mar 09 1959 | |
| thiotepa | Thioplex | Immunex Corporation | Dec 22 1994 | |
| thiotepa | Thioplex | Lederle Laboratories | Aug 15 1990 | |
| topotecan | Hycamtin | Treatment of patients with metastatic carcinoma of the ovary after failure of initial or subsequent chemotherapy. | GlaxoSmithKline | May 28 1996 |
| topotecan | Hycamtin | Treatment of small cell lung cancer sensitive disease after failure of first-line chemotherapy. In clinical studies submitted to support approval, sensitive disease was defined as disease responding to chemotherapy but subsequently progressing at least 60 days (in the phase 3 study) or at least 90 days (in the phase 2 studies) after chemotherapy | GlaxoSmithKline | Nov 30 1998 |
| topotecan hcl | Hycamtin | Cervical carcinoma | GlaxoSmithKline | Jun 14 2006 |
| toremifene | Fareston | Treatment of advanced breast cancer in postmenopausal women. | Orion Corp. | May 29 1997 |
| Tositumomab | Bexxar | Accel. Approv. (clinical benefit not established) Treatment of patients with CD20 positive, follicular, non-Hodgkin's lymphoma, with and without transformation, whose disease is refractory to Rituximab and has relapsed following chemotherapy | Corixa Corporation | Jun 27 2003 |
| Tositumomab/I-131 tositumomab | Bexxar | Expand the indication to include patients with relapsed or refractory low grade follicular transformed CD20-positive non-Hodgkin's lymphoma who have not received rituximab | GlaxoSmithKline | Dec 22 2004 |
| trastuzumab | Herceptin | Early Stage Breast Cancer After Primary Therapy | Genentech | Nov 16 2006 |
| Trastuzumab | Herceptin | HERCEPTIN as a single agent is indicated for the treatment of patients with metastatic breast cancer whose tumors overexpress the HER2 protein and who have received one or more chemotherapy regimens for their metastatic disease. | Genentech, Inc | Sep 25 1998 |
| Trastuzumab | Herceptin | Herceptin in combination with paclitaxel is indicated for treatment of patients with metastatic breast cancer whose tumors overexpress the HER-2 protein and had not received chemotherapy for their metastatic disease | Genentech, Inc | Feb 09 2000 |
| Trastuzumab | Herceptin | Genentech, Inc | Aug 28 2002 | |
| Trastuzumab | Herceptin | Genentech, Inc | Aug 28 2002 | |
| tretinoin, ATRA | Vesanoid | Induction of remission in patients with acute promyelocytic leukemia (APL) who are refractory to or unable to tolerate anthracycline based cytotoxic chemotherapeutic regimens. | Roche | Nov 22 1995 |
| Uracil Mustard | Uracil Mustard Capsules | Roberts Labs | Sep 13 1962 | |
| valrubicin | Valstar | For intravesical therapy of BCG-refractory carcinoma in situ (CIS) of the urinary bladder in patients for whom immediate cystectomy would be associated with unacceptable morbidity or mortality. | Anthra --> Medeva | Sep 25 1998 |
| vinblastine | Velban | Eli Lilly | Nov 05 1965 | |
| vincristine | Oncovin | Eli Lilly | Jul 10 1963 | |
| vincristine | Oncovin | Eli Lilly | Jul 10 1963 | |
| vincristine | Oncovin | Eli Lilly | Jul 10 1963 | |
| vincristine | Oncovin | Eli Lilly | Jul 10 1963 | |
| vincristine | Oncovin | Eli Lilly | Jul 10 1963 | |
| vincristine | Oncovin | Eli Lilly | Jul 10 1963 | |
| vincristine | Oncovin | Eli Lilly | Jul 10 1963 | |
| vinorelbine | Navelbine | Single agent or in combination with cisplatin for the first-line treatment of ambulatory patients with unresectable, advanced non-small cell lung cancer (NSCLC). | GlaxoSmithKline | Dec 23 1994 |
| vinorelbine | Navelbine | Navelbine is indicated as a single agent or in combination with cisplatin for the first-line treatment of ambulatory patients with unreseactable, advanced non-small cell lung cancer (NSCLC). In patients with Stage IV NSCLC, Navelbine is indicated as a single agent or in combination with cisplatin. In Stage III NSCLC, Navelbine is indicated in combination with cisplatin. | GlaxoSmithKline | Nov 05 2002 |
| vorinostat | Zolinza | for the treatment of cutaneous manifestations of cutaneous T-cell lymphoma (CTCL) in patients with progressive, persistent, or recurrent disease on or following two systemic therapies. | Merck | Oct 06 2006 |
| zoledronate | Zometa | the treatment of patients with multiple myeloma and patients with documented bone metastases from solid tumors, in conjunction with standard antineoplastic therapy. Prostate cancer should have progressed after treatment with at least one hormonal therapy | Novartis | Feb 22 2002 |
| zoledronic acid | Zometa | Treatment of hypercalcemia of malignancy | Novartis | Aug 20 2001 |
http://www.fda.gov/cder/cancer/druglistframe.htm
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