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FDA Approved Drugs » Therapeutic Areas

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FDA Approved Drugs by Therapeutic Area

Search by therapeutic area for drugs approved by the Food and Drug Administration (FDA) for sale in the United States. Click on an area below to view the complete list of drugs in that category or review descriptions for our therapeutic area list to assist you in your search.

Find out more about the types of drugs included in this listing.

FDA Approved Drugs for Oncology

Drugs Approved in 2014

Beleodaq (belinostat); Spectrum Pharmaceuticals; For the treatment of relapsed or refractory peripheral T-cell lymphoma, Approved July 2014

Cyramza (ramucirumab); Eli Lilly; For the treatment of gastric cancer, Approved April 2014

Imbruvica (ibrutinib); Pharmacyclics; For the treatment of chronic lymphocytic leukemia, Approved February 2014

Keytruda (pembrolizumab); Merck; For the treatment of unresectable or metastatic melanoma, Approved September 2014

Zydelig (idelalisib); Gilead; For the treatment of relapsed CLL, follicular B-cell NHL and small lymphocytic lymphoma, Approved July 2014

Zykadia (ceritinib); Novartis; For the treatment of ALK+ metastatic non-small cell lung cancer, Approved April 2014

Drugs Approved in 2013

Gazyva (obinutuzumab); Genentech; For the treatment of previously untreated chronic lymphocytic leukemia, Approved October of 2013

Gilotrif (afatinib); Boehringer Ingelheim; For the treatment of metastatic non-small cell lung cancer with EGFR mutations, Approved July 2013

Imbruvica (ibrutinib); Pharmacyclics; For the treatment of mantle cell lymphoma, Approved November of 2013

Kadcyla (ado-trastuzumab emtansine); Genentech; For the treatment of HER2-positive metastatic breast cancer, Approved February 2013

Mekinist (trametinib); GlaxoSmithKline; For the treatment of unresectable or metastatic melanoma with BRAF V600E or V600K mutations, Approved May of 2013

Pomalyst (pomalidomide); Celgene; For the treatment of relapsed and refractory multiple myeloma, Approved February 2013

Revlimid (lenalidomide); Celgene; For the treatment of mantle cell lymphoma, Approved June 2013

Stivarga (regorafenib); Bayer; For the treatment of gastrointestinal stromal tumor, Approved February 2013

Tafinlar (dabrafenib); GlaxoSmithKline; For the treatment of unresectable or metastatic melanoma with BRAF V600E mutation, Approved May 2013

Valchlor (mechlorethamine) gel; Ceptaris Therapeutics; For the treatment of Stage IA/IB mycosisfungoides-type cutaneous T-cell lymphoma, Approved August 2013

Xgeva (denosumab); Amgen; For the treatment of giant cell tumor of bone, Approved June 2013

Xofigo (radium Ra 223 dichloride); Bayer Healthcare Pharmaceuticals; For the treatment of prostate cancer with bone metastases, Approved May 2013

Drugs Approved in 2012

Abraxane (paclitaxel protein-bound particles for injectable suspension); Celgene; For the treatment of non-small cell lung cancer, Approved October 2012

Afinitor (everolimus); Novartis; For the treatment of renal angiomyolipoma associated with tuberous sclerosis complex, Approved April 2012

Afinitor (everolimus); Novartis; For the treatment of hormone receptor-positive, HER2-negative breast cancer, Approved July 2012

Bosulif (bosutinib); Pfizer; For the treatment of Ph+ chronic myelogenous leukemia, Approved September 2012

Cometriq (cabozantinib); Exelixis; For the treatment of metastatic medullary thyroid cancer, Approved November 2012

Erivedge (vismodegib); Genentech; For the treatment of basal cell carcinoma, Approved January 2012

Iclusig (ponatinib); Ariad Pharmaceuticals; For the treatment of chronic myeloid leukemia and Philadelphia chromosome positive acute lymphoblastic leukemia, Approved December 2012

Inlyta (axitinib); Pfizer; For the treatment of advanced renal cell carcinoma, Approved January 2012

Kyprolis (carfilzomib); Onyx Pharmaceuticals; For the treatment of multiple myeloma, Approved July 2012

Marqibo (vinCRIStine sulfate LIPOSOME injection); Talon Therapeutics; For the treatment of Ph- acute lymphoblastic leukemia, Approved August 2012

Neutroval (tbo-filgrastim); Teva Pharmaceutical; For the reduction in the duration of severe chemotherapy-induced neutropenia, Approved August 2012

Perjeta (pertuzumab); Genentech; For the first-line treatment of HER2+ metastatic breast cancer, Approved June 2012

Picato (ingenol mebutate) gel; LEO Pharma; For the treatment of actinic keratosis, Approved January 2012

Stivarga (regorafenib); Bayer HealthCare Pharmaceuticals; For the treatment of previously treated patients with metastatic colorectal cancer, Approved September 2012

Subsys (fentanyl sublingual spray); Insys Therapeutics; For the treatment of breakthrough cancer pain, Approved January of 2012

Synribo (omacetaxine mepesuccinate); Teva Pharmaceutical; For the treatment of chronic or accelerated phase chronic myeloid leukemia, Approved October 2012

Votrient (pazopanib); GlaxoSmithKline; For the treatment of soft tissue sarcoma, Approved April 2012

Xtandi (enzalutamide); Medivation; For the treatment of metastatic castration-resistant prostate cancer, Approved August 2012

Zaltrap (ziv-aflibercept); Sanofi-aventis; For the treatment of metastatic colorectal cancer, Approved August 2012

Drugs Approved in 2011

Abstral (fentanyl sublingual tablets); ProStrakan; For the treatment of breakthrough cancer pain in opioid-tolerant patients, Approved January 2011

Adcetris (brentuximab vedotin); Seattle Genetics; For the treatment of Hodgkin lymphoma and anaplastic large cell lymphoma, Approved August 2011

Afinitor (everolimus); Novartis; For the treatment of advanced pancreatic neuroendocrine tumors, Approved May 2011

Erwinaze (asparaginase Erwinia chrysanthemi); Eusa Pharma; For the treatment of acute lymphoblastic leukemia, Approved November of 2011

Lazanda (fentanyl citrate) nasal spray; Archimedes; For the management of breakthrough cancer pain, Approved June 2011

Sutent (sunitinib malate); Pfizer; For the treatment of pancreatic neuroendocrine tumors, Approved May 2011

Sylatron (peginterferon alfa-2b); Merck; For the treatment of melanoma, Approved April 2011

Vandetanib (vandetanib); AstraZeneca; For the treatment of thyroid cancer, Approved April 2011

Xalkori (crizotinib); Pfizer; For the treatment of ALK+ non-small cell lung cancer, Approved August of 2011

Yervoy (ipilimumab); Bristol-Myers Squibb; For the treatment of metastatic melanoma, Approved March 2011

Zelboraf (vemurafenib); Roche; For the treatment of BRAF + melanoma, Approved August of 2011

Zytiga (abiraterone acetate); Centocor Ortho Biotech; For the treatment of prostate cancer, Approved May 2011

Drugs Approved in 2010

Halaven (eribulin mesylate); Eisai; For the treatment of metastatic breast cancer, Approved November 2010

Herceptin (trastuzumab); Genentech; For the treatment of gastric cancer, Approved October 2010

Jevtana (cabazitaxel); sanofi aventis; For the treatment of prostate cancer, Approved June 2010

Provenge (sipuleucel-T); Dendreon; For the treatment of hormone refractory prostate cancer, Approved May 2010

Xgeva (denosumab); Amgen; For the prevention of skeletal-related events in patients with bone metastases from solid tumors, Approved November 2010

Zuplenz (ondansetron oral soluble film); Strativa Pharmaceuticals; For the prevention of post-operative, chemotherapy and radiotherapy induced nausea and vomiting, Approved July 2010

Drugs Approved in 2009

Afinitor (everolimus); Novartis; For the treatment of renal cell carcinoma, Approved March 2009

Arzerra (ofatumumab); GlaxoSmithKline; For the treatment of chronic lymphocytic leukemia, Approved October 2009

Avastin (bevacizumab); Genentech; For the treatment of renal cell carcinoma, Approved July 2009

Cervarix [Human Papillomavirus Bivalent (Types 16 and 18) Vaccine, Recombinant; GlaxoSmithKline; For the prevention of cervical cancer and cervical intraepithelial neoplasia caused by HPV types 16 and 18, Approved October 2009

Elitek (rasburicase); sanofi-aventis; For the management of plasma uric acid levels in adults with malignancies, Approved October 2009

Folotyn (pralatrexate injection); Allos Therapeutics; For the treatment of peripheral T-cell lymphoma, Approved September 2009

Istodax (romidepsin); Gloucester Pharmaceuticals; For the treatment of cutaneous T-cell lymphoma, Approved November 2009

Onsolis (fentanyl buccal); BioDelivery Sciences; For the management of breakthrough cancer pain, Approved July 2009

Votrient (pazopanib); GlaxoSmithKline; For the treatment of renal cell carcinoma, Approved October of 2009

Drugs Approved in 2008

Degarelix (degarelix for injection); Ferring Pharmaceuticals; For the treatment of prostate cancer, Approved December of 2008

Fusilev (levoleucovorin); Spectrum Pharmaceuticals; For rescue after high-dose methotrexate therapy in osteosarcoma and to reduce the toxicity of methotrexate, Approved March of 2008

Mozobil (plerixafor injection); Genzyme; For the treatment of non-Hodgkin’s lymphoma and multiple myeloma, Approved December 2008

Sancuso (granisetron); ProStrakan; For the treatment of chemotherapy-induced nausea and vomiting, Approved September 2008

Treanda (bendamustine hydrochloride); Cephalon; For the treatment of Chronic lymphocytic leukemia and B-cell non-Hodgkin’s lymphoma, Approved October 2008

Drugs Approved in 2007

Evista (raloxifene hydrochloride); Eli Lilly; For the treatment/prevention of osteoporosis and reduction of breast cancer risk in postmenopausal women, Approved September 2007

Hycamtin (topotecan hydrochloride); GlaxoSmithKline; For the treatment of small cell lung cancer, Approved October 2007

Ixempra (ixabepilone); Bristol-Myers Squibb; For the treatment of breast cancer, Approved October 2007

Tasigna (nilotinib hydrochloride monohydrate); Novartis; For the treatment of chronic myelogenous leukemia, Approved October 2007

Torisel (temsirolimus); Wyeth; For the treatment of renal cell carcinoma, Approved May 2007

Tykerb (lapatinib); GlaxoSmithKline; For the treatment of breast cancer, Approved March 2007

Drugs Approved in 2006

Gardasil (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine); Merck; For the prevention of cervical cancer associated with human papillomavirus, Approved June 2006

Sprycel (dasatinib); Bristol-Myers Squibb; For the treatment of imatinib-resistant chronic myeloid leukemia, Approved June 2006

Sutent (sunitinib); Pfizer; For the treatment of kidney cancer and gastrointestinal stromal tumors, Approved January 2006

Vectibix (panitumumab); Amgen; For the treatment of colorectal cancer, Approved September 2006

Drugs Approved in 2005

Arranon (nelarabine); GlaxoSmithKline; For the treatment of T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma, Approved October 2005

Nexavar (sorafenib); Bayer/Onyx; For the Treatment of Renal Cell Carcinoma, Approved December 2005

Drugs Approved in 2004

Alimta (pemetrexed for injection); Eli Lilly; For the treatment of malignant pleural mesothelioma, Approved February 2004

Avastin (bevacizumab); Genentech; For the treatment of metastatic carcinoma of the colon or rectum, Approved February 2004

Clolar (clofarabine); Genzyme; For the treatment of acute lymphoblastic leukemia in pediatric patients, Approved December, 2004

Erbitux (cetuximab); Imclone, Bristol-Myers Squibb; For the treatment of EGFR-expressing, metastatic colorectal cancer, Approved February 2004

Sensipar (cinacalcet); Amgen; For the treatment of secondary hyperparathyroidism and hypercalcemia in parathyroid carcinoma patients, Approved March 2004

Tarceva (erlotinib, OSI 774); Genentech, OSI Pharmaceuticals; For the treatment of advanced refractory metastatic non-small cell lung cancer, Approved November, 2004

Drugs Approved in 2003

Aloxi (palonosetron); MGI Pharma, Helsinn Healthcare; For the prevention of nausea and vomiting associated with emetogenic cancer chemotherapy, Approved August 2003

Bexxar; Corixa; For the treatment of patients with CD20 positive, follicular, non-Hodgkin's lymphoma following chemotherapy relapse, Approved June 2003

Emend (aprepitant); Merck; For the treatment of nausea and vomiting associated with chemotherapy, Approved March 2003

Iressa (gefitinib); AstraZeneca; For the second-line treatment of non-small-cell lung cancer, Approved May 2003

Plenaxis (abarelix for injectable suspension); Praecis Pharmaceuticals; For treatment of advanced prostate cancer, Approved December 2003

Premarin (conjugated estrogens); Wyeth; For the prevention of postmenopausal osteoporosis and treatment of vasomotor menopause symptoms, Approved July of 2003

UroXatral (alfuzosin HCl extended-release tablets); Sanofi-aventis; For the treatment of of the signs and symptoms of benign prostatic hyperplasia, Approved June 2003

Velcade (bortezomib); Millennium Pharmaceuticals; Injectable agent for the treatment of multiple myeloma patients who have received at least two prior therapies., Approved May 2003

Drugs Approved in 2002

Eligard (leuprolide acetate); Atrix Laboratories; For the palliative treatment of advanced prostate cancer, Approved January 2002

Eloxatin (oxaliplatin/5-fluorouracil/leucovorin); Sanofi-aventis; For the treatment of colon or rectum carcinomas, Approved August 2002

Faslodex (fulvestrant); AstraZeneca; For the treatment of hormone receptor positive metastatic breast cancer, Approved April 2002

Gleevec (imatinib mesylate); Novartis; For the treatment of gastrointestinal stromal tumors (GISTs), Approved February 2002

Neulasta; Amgen; Treatment to decrease the chance of infection by febrile neutropenia in patients receiving chemotherapy, Approved January 2002

SecreFlo (secretin); Repligen; To aid in the diagnosis of pancreatic dysfunction and gastrinoma, Approved April 2002

Zevalin (ibritumomab tiuxetan); Biogen IDEC; For the treatment of non-Hodgkin's lymphoma, Approved February 2002

Zometa (zoledronic acid); Novartis; For the treatment of multiple myeloma and bone metastases from solid tumors, Approved February 2002

Drugs Approved in 2001

Campath; Berlex Laboratories; Injectable treatment of B-cell chronic lymphocytic leukemia, Approved May 2001

Femara (letrozole); Novartis; First-line treatment of postmenopausal women with locally advanced or metastatic breast cancer, Approved January 2001

Gleevec (imatinib mesylate); Novartis; Oral therapy for the treatment of chronic myeloid leukemia, Approved May 2001

Kytril (granisetron) solution; Roche; For the prevention of nausea and vomiting associated with cancer therapy, Approved June 2001

Trelstar LA (triptorelin pamoate); Debiopharm; Intramuscular injection for the treatment of advanced stage prostate cancer, Approved June 2001

Xeloda; Roche; Oral chemotherapy for the treatment of metastatic colorectal cancer, Approved May 2001

Zometa (zoledronic acid); Novartis; For the treatment of hypercalcemia of malignancy, Approved August 2001

Drugs Approved in 2000

Mylotarg (gemtuzumab ozogamicin); Wyeth; For the treatment of CD33 positive acute myeloid leukemia (AML), Approved May 2000

Trelstar Depot (triptorelin pamoate); Debio Rechereche Pharmaceutique, Target Research Associates; For the palliative treatment of advanced prostate cancer, Approved June 2000

Trisenox (arsenic trioxide); Cell Therapeutics; For the induction of remission and consolidation in patients with acute promyelocytic leukemia (APL), Approved September 2000

Viadur (leuprolide acetate implant); Alza; For pain relief in men with advanced prostate cancer, Approved March 2000

Drugs Approved in 1999

Aromasin Tablets; Pharmacia & Upjohn; Exemestane Tablets, 25 mg, October 21, 1999

Busulflex; Orphan Medical; For use in combination for the treatment of leukemia, Approved February 1999

Doxil (doxorubicin HCl liposome injection); Alza; Treatment for ovarian cancer that is refractory to other first-line therapies, Approved June 1999

Ellence; Pharmacia & Upjohn; epirubicin hydrochloride, Approved September 1999

Ethyol (amifostine); US Bioscience, Alza; Treatment for xerostomia (dry mouth) due to radiation, Approved June 1999

Temodar; Schering-Plough; Treatment for refractory anaplastic astrocytoma, Approved August 1999

UVADEX Sterile Solution; Therakos; Treatment of the skin manifestations of cutaneous T-cell lymphoma (CTCL), Approved February 1999

Zofran; GlaxoSmithKline; Treatment for the prevention of chemotherapy and radiation-induced nausea, Approved January 1999

Drugs Approved in 1998

Actiq; Anesta Corporation; Treatment for Cancer Pain, Approved November 1998

Anzemet; Hoechst Marion Roussel; Treatment for the prevention of nausea and vomiting associated with chemotherapy and surgery, Approved February 1998

Camptosar; Pharmacia & Upjohn; Treatment for Colon or Rectal Cancer, Approved October 1998

Gemzar (gemcitabine HCL); Eli Lilly; Treatment for Lung Cancer, Approved August 1998

Herceptin; Genentech; Treatment for metastatic breast cancer, Approved October 1998

Inform HER-2/neu breast cancer test; Oncor; Treatment for breast cancer prediction, Approved January 1998

Neupogen; Amgen; Treatment for slow white blood cell recovery following chemotherapy, Approval April 1998

Nolvadex; AstraZeneca; Treatment for Breast Cancer, Approved October 1998

Photofrin; QLT; Treatment for early-stage, microinvasive endobronchial non-small cell lung cancer, Approved January 1998

Proleukin; Chiron; Treatment for metastatic melanoma, Approved January 1998

Sclerosol Intrapleural Aerosol; Bryan Corporation; Treatment for malignant pleural effusions, Approved January 1998

Valstar; Anthra Pharmaceuticals; Treatment for Bladder Cancer, Approved October 1998

Xeloda; Roche; Treatment for advanced breast cancer tumors, Approved April 1998

Zofran; GlaxoSmithKline; Treatment for postoperative vomiting and nausea in adults, Approved April 1998

Drugs Approved in 1997

Anzemet; Hoechst Marion Roussel; Treatment for emesis, Approved September 1997

Bromfenac; Duract, Wyeth-Ayerst Laboratories; Management of acute pain, Approved July 1997

Femara (letrozole); Novartis; Treatment for breast cancer, Approved July 1997

Gliadel Wafer (polifeprosan 20 with carmustine implant); Rhone-Poulenc Rorer, Guilford Pharmaceuticals; Treatment for brain cancer, Approved February 1997

Intron A (interferon alfa-2b, recombinant); Schering-Plough; Treatment for non-Hodgkin's lymphoma, Approved December 1997

Kytril (granisetron) tablets; SmithKline Beecham; Prevention of nausea and vomiting associated with chemotherapy, Approved November 1997

Lupron Depot (leuprolide acetate for depot suspension); TAP Pharmaceuticals; Treatment for prostate cancer, Approved July 1997

Miraluma test; DuPont Merck Pharmaceutical Company; Test for breast cancer, Approved May 1997

Neumega; Genetics Institute; Treatment for thrombocytopenia, Approved November 1997

Quadramet (Samarium Sm 153 Lexidronam Injection); DuPont Merck Pharmaceutical Company; Treatment for pain associated with bone cancer, Approved March 1997

Rituxan; Biogen IDEC, Genentech; Treatment for non-hodgkin's lymphoma, Approved November 1997

Taxol; Bristol-Myers Squibb; Treatment for AIDS-related Kaposi's Sarcoma, Approved August 1997

Drugs Approved in 1996

Anexsia; Mallinckrodt Group; Treatment for chronic pain, Approved August 1996

Aredia (pamidronate disodium for injection); Chiron; Treatment for osteolytic bone metastases of breast cancer, Approved August 1996

Arimidex (anastrozole); AstraZeneca; Treatment for advanced breast cancer in postmenopausal women, Approved January 1996

Campostar; Pharmacia & Upjohn; Treatment for metastatic colorectal cancer, Approved June 1996

CEA-Scan; Immunomedics; Diagnostic imaging product for colorectal cancer, Approved April 1996

Elliotts B Solution (buffered intrathecal electrolyte/dextrose injection); Orphan Medical; Treatment of meningeal leukemia or lymphocytic lymphoma, Approved October 1996

Eulexin (flutamide); Schering-Plough; Treatment for prostate cancer, Approved June 1996

Feridex I.V.; Advanced Magnetics; Contrast agent for magnetic resonance imaging of liver lesions, Approved February 1996

GastroMARK; Advanced Magnetics; Contrast agent for magnetic resonance imaging of the gastrointestinal tract, Approved May 1996

Gemzar (gemcitabine HCL); Eli Lilly; Treatment for pancreatic cancer, Approved May 1996

Hycamtin (topotecan hydrochloride); SmithKline Beecham; Treatment for metastatic ovarian cancer, Approved May 1996

Kadian; Purepac Pharmaceutical; Treatment for chronic moderate to severe pain, Approved July 1996

Leukine (sargramostim); Immunex; Treatment for the replenishment of white blood cells, Approved November 1996

Lupron Depot (leuprolide acetate for depot suspension); Abbott Laboratories; Treatment for advanced prostate cancer, Approved January 1996

Photodynamic Therapy; Sanofi-aventis; Photodynamic therapy device for the treatment of esophageal cancer, Approved January, 1996

Taxotere (Docetaxel); Rhone Poulenc Rorer; Treatment for locally advanced or metastatic breast cancer, Approved May 1996

UltraJect; Mallinckrodt Group; Treatment for chronic pain, Approved August 1996

Visipaque (iodixanol); Nycomed; Diagnostic contrast agent, Approved April 1996

Zoladex (10.8 mg goserelin acetate implant); AstraZeneca; Treatment for advanced prostate cancer, Approved January 1996

Drugs Approved in 1995

Ethyol (amifostine); Alza; Treatment to reduce renal toxicity associated with chemotherapy in subjects with advanced ovarian cancer, Approved December 8, 1995

Intron A (Interferon alfa-2b, recombinant); Schering-Plough; An adjuvant treatment to surgery in subjects at high risk for systemic recurrence of malignant melanoma, Approved December 1995

Leukine (sargramostim); Immunex; Treatment for mobilizing peripheral blood progenitor cells for use after transplantation., Approved on November 24, 1995

Self-examination breast pad; Inventive Products; Self-examination breast pad, Approved on December 22, 1995

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