| Drug | Drug Trade Name | Approved Use | Manufacturer/Distributor | Approval Date |
|---|---|---|---|---|
| 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. | Glaxo Smith Kline | 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 | 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 |
| 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 |
| bexarotene | 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 | 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 | Sclerosing agent for the treatment of malignant pleural effusion (MPE) and prevention of recurrent pleural effusions. | Bristol-Myers Squibb | Feb 20 1996 |
| 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 | Glaxo Smith Kline | Jun 26 1954 |
| capecitabine | Xeloda | 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 | Treatment in combination with docetaxel of patients with metastatic breast cancer after failure of prior anthracycline containing chemotherapy | Roche | Sep 07 2001 |
| 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 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 | Reduction of polyp number in patients with the rare genetic disorder of familial adenomatous polyposis. | Searle | Dec 23 1999 |
| chlorambucil | Leukeran | Chronic Lymphocytic Leukemia- palliative therapy | Glaxo Smith Kline | 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 |
| cisplatin-epinephrine gel | IntraDose(R), FocaCis(R) | not approved | Matrix Pharmaceutical | |
| cladribine | Leustatin, 2-CdA | Treatment of active hairy cell leukemia. | R.W. Johnson Pharmaceutical Research Institute | Feb 26 1993 |
| cytarabine liposomal | DepoCyt | Intrathecal therapy of lymphomatous meningitis | Skye Pharmaceuticals | Apr 01 1999 |
| 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 Res | Mar 11 1987 |
| dexrazoxane | Zinecard | Prevention of cardiomyopathy associated with doxorubicin administration | Pharmacia & Upjohn Company | May 26 1995 |
| docetaxel | Taxotere | For the 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 | 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 | For locally advanced or metastatic non-small cell lung cancer after failure of prior platinum-based chemotherapy. | Aventis Pharmaceutical | Dec 23 1999 |
| doxorubicin | Adriamycin PFS Injection | Antibiotic, antitumor agent. | Pharmacia & Upjohn Company | Dec 23 1987 |
| doxorubicin liposomal | Doxil | 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 | 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 |
| 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 |
| 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 | 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 | 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 |
| exemestane | Aromasin | Treatment of advance breast cancer in postmenopausal women whose disease has progressed following tamoxifen therapy. | Pharmacia & Upjohn Company | Oct 21 1999 |
| 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 |
| 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 And Company | 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 And Company | Aug 25 1998 |
| gemtuzumab-ozogamicin | Mylotarg | 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 Res | May 17 2000 |
| goserelin acetate | Zoladex Implant | Palliative treatment of advanced breast cancer in pre- and perimenopausal women. | AstraZeneca Pharmaceuticals | Dec 18 1995 |
| hydroxyurea | Hydrea Capsules | Decrease need for transfusions in sickle cell anemia | Bristol-Myers Squibb | Feb 25 1998 |
| 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 | Initial therapy of chronic myelogenous leukemia | Novartis | May 10 2001 |
| imatinib mesylate | Gleevec | metastatic or unresectable malignant gastrointestinal stromal tumors | Novartis | Feb 01 2002 |
| 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 |
| irinotecan | Camptosar | 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 | Follow up of 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 |
| 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 |
| 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 | In combination with fluorouracil to prolong survival in the palliative treatment of patients with advanced colorectal cancer. | Lederle Laboratories | Dec 12 1991 |
| 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 |
| liposomal daunorubicin | DaunoXome | "DaunoXome is indicated as a first line cytotoxic therapy for advanced HIV-associated Kaposi's Sarcoma. DaunoXome is not recommended in patients with less than advnanced HIV-related Kaposi's Sarcoma." | Vestar, Inc | Jan 28 1994 |
| melphalan, L-PAM | Alkeran | Systemic administration for palliative treatment of patients with multiple myeloma for whom oral therapy is not appropriate. | Glaxo Smith Kline | Nov 18 1992 |
| mesna | Mesnex | Prevention of ifosfamide-induced hemorrhagic cystitis | Asta Medica | Dec 30 1988 |
| methotrexate | Methotrexate | osteosarcoma | Lederle Laboratories | Apr 07 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 |
| 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 |
| 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 | 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 | 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 | 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 | First line ovarian cancer with 3 hour infusion. | Bristol-Myers Squibb | Jun 20 2000 |
| 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 | 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 |
| pamidronate | Aredia | Treatment of osteolytic bone metastases of breast cancer in conjunction with standard antineoplastic therapy. | Novartis | Sep 22 1998 |
| Pegademase | Adagen (Pegademase Bovine) | Enzyme replacement therapy for patients with severe combined immunodeficiency asa result of adenosine deaminase deficiency. | Enzon | Mar 21 1990 |
| 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 |
| 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 |
| streptozocin | Zanosar | Antineoplastic agent. | Pharmacia & Upjohn Company | May 07 1982 |
| talc | Sclerosol | For the prevention of the recurrence of malignant pleural effusion in symptomatic patients. | Bryan | Dec 24 1997 |
| tamoxifen | Nolvadex | to reduce the incidence of breast cancer in women at high risk for breast cancer | AstraZeneca Pharmaceuticals | Oct 29 1998 |
| tamoxifen | Nolvadex | Metastatic breast cancer in men. | AstraZeneca Pharmaceuticals | Apr 01 1993 |
| 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 | 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 |
| temozolamide | Temodar | 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 |
| 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 |
| topotecan | Hycamtin | Treatment of patients with metastatic carcinoma of the ovary after failure of initial or subsequent chemotherapy. | Glaxo Smith Kline | 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 | Glaxo Smith Kline | Nov 30 1998 |
| toremifene | Fareston | Treatment of advanced breast cancer in postmenopausal women. | Orion Corp. | May 29 1997 |
| 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 |
| 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 |
| 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). | Glaxo Smith Kline | Dec 23 1994 |
| 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 |