NDA or BLA # | Proprietary Name (Established or Proper Name) | Applicant | Approval Date | Use |
|---|---|---|---|---|
| BL125147 | Vectibix (panitumumab) | Amgen | 9/27/2006 | Treatment of metastatic carcinoma of the colon or rectum in patients who have failed standard, irinotecan- and/or oxaliplatin-containing, chemotherapy regimens. |
| BL125151 | Elaprase (idursulfase) | Transkaryotic | 7/24/2006 | Enzyme replacement therapy for patients with Hunter syndrome(Mucopolysaccharidosis II, MPS II) |
N21937 | Atripla (emtricitabine; tenofovir disoproxil fumarate; efavirenz) | Gilead Sciences | 7/12/2006 | Treatment of HIV |
| N21986 | Sprycel (dosatinib) | Bristol Myers-Squibb | 6/28/2006 | Treatment of chronic myelogenous leukemia |
| N21976 | Prezista (darunavir) | Tibotec | 6/23/2006 | Treatment of HIV |
| N21790 | Dacogen (decitabine) | Supergen | 5/2/2006 | Treatment of myelodysplastic syndromes |
| BL125141 | Myozyme (alglucosidase alfa) | Genzyme | 4/28/2006 | Treatment of patients with a confirmed diagnosis of Pompe disease (GAA deficiency) |
| N21903 | NeoProfen (ibuprofen lysine) | Farmacon-IL | 4/13/2006 | Treatment of patent ductus arteriosis (PDA) |
| N21880 | Revlimid (lenalidomide) | Celgene | 12/27/2005 | Treatment of transfusion-dependent Myelodysplastic Syndromes (MDS) |
| N21923 | Nexavar (sorafenib tosylate) | Bayer | 12/20/2005 | Treatment of renal cell carcinoma |
| BL125118 | Orencia (abatacept) | Bristol-Myers Squibb | 11/23/2005 | Treatment of moderately to severely active rheumatoid arthritis in adult patients who have had an inadequate response to one or more Disease Modifying Anti-Rheumatoid Drugs |
| N21882 | Exjade (deferasirox) | Novartis | 11/2/2005 | Iron chelating compound for first-line treatment of chronic iron overload; thalassemia in adults and children with transfusion-dependent anemias |
| N21877 | Arranon (nelarabine) | GlaxoSmithKline | 10/28/2005 | Treatment of refractory or relapsed T-cell acute lymphoblastic leukemia (ALL) or non-Hodgkin's lymphoma in pediatric patients under the age of 21 |
| BL103772 5113.0 | Remicade (infliximab) | Centocor | 9/15/2005 | Treatment of moderately to severely active ulcerative colitis in patients who had an inadequate response to conventional therapy |
| BL125117 | Naglazyme (galsulfase) | BioMarin | 5/31/2005 | Treatment of patients with Mucopolysaccharidosis type VI (MPS-VI) |
| N21737 | Retisert (fluocinolone acetonide) | Bausch & Lomb | 4/8/2005 | Treatment of chronic non-infectious uveitis affecting the posterior segment of the eye |
| BL103964 5039.0 | Pegasys(peginterferon alfa-2a) | Hoffmann-La Roche | 2/25/2005 | Alone or in combination with ribavirin (Copegus) for treatment of chronic hepatitis C in patients co-infected with HIV, who have clinically stable HIV disease |
| N21660 | Abraxane (paclitaxel protein-bound particles for injectable suspension) | American BioScience | 1/7/2005 | Treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy |
| N21673 | Clolar (clofarabine) | Genzyme | 12/28/2004 | Treatment of pediatric patients 1 to 21 years old with relapsed or refractory acute lymphoblastic leukemia after at least two prior regimens |
| BL125011 24.0 | Bexxar (tositumomab and iodine I 131 tositumomab) | Corixa | 12/22/2004 | Expand the indication to include patients with relapsed or refractory, low-grade, follicular or transformed CD20 positive non-Hodgkin's lymphoma who have not received rituximab |
| N21756 | Macugen (pegaptanib sodium) | Eyetech Pharms | 12/17/2004 | Treatment of exudative (wet) age-related macular degeneration |
| BL125103 | Kepivance (palifermin) | Amgen | 12/15/2004 | Decrease the incidence and duration of severe oral mucositis in patients with hematologic malignancies receiving myelotoxic therapy requiring hematopoietic stem cell support |
| N20635 SE1-035 | Levaquin (levofloxacin) | Ortho McNeil | 11/24/2004 | Treatment of inhalational anthrax (post-exposure) |
| N20634 SE1-035 | Levaquin (levofloxacin) | Ortho McNeil | 11/24/2004 | Treatment of inhalational anthrax (post-exposure) |
| N21743 | Tarceva (erlotinib) | OSI Pharms | 11/18/2004 | Treatment of locally advanced or metastatic Non Small-Cell Lung Cancer after failure of at least one prior chemotherapy regimen |
| N21677 | Alimta (pemetrexed) | Lilly | 8/19/2004 | Treatment of non-small cell lung cancer |
| N50794 | Vidaza (azacitidine) | Pharmion | 5/19/2004 | Treatment of patients with certain subtypes of myelodysplastic syndrome |
| N21264 | Apokyn (apomorphine) | Bertek | 4/20/2004 | Treatment of acute, intermittent hypomobility, "off" episodes ("end-of-dose wearing off" and unpredictable "on/off" episodes) associated with advanced Parkinson’s disease |
| BL125085 | Avastin (bevacizumab) | Genentech | 2/26/2004 | For the first-line treatment of patients with metastatic carcinoma of the colon and rectum (in combination with intravenous 5-fluorouracil-based chemotherapy) |
| BL125084 | Erbitux (cetuximab) | ImClone Systems | 2/12/2004 | Treatment of EGFR-expressing, metastatic colorectal carcinoma in patients who are refractory to irinotecan-based chemotherapy (in combination with irinotecan); treatment of EGFR-expressing, metastatic colorectal carcinoma in patients who are intolerant to irinotecan-based chemotherapy (administered as a single agent) |
| N21462 | Alimta (pemetrexed disodium) | Lilly | 2/4/2004 | Treatment of malignant pleural mesothelioma |
| N21548 | Lexiva (fosamprenavir calcium) | GlaxoSmithKline | 10/20/2003 | Treatment of HIV |
| N21348 | Zavesca (miglustat) | Actelion Pharms | 7/31/2003 | Treatment of type I Gaucher disease |
| N21500 | Emtriva (emtricitabine) | Gilead | 7/2/2003 | Treatment of HIV |
| BL125011 | Bexxar (tositumomab and iodine I 131 tositumomab) | Corixa Corporation | 6/27/2003 | 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. |
| N21602 | Velcade (bortezomib) | Millennium Pharms | 5/13/2003 | Treatment of relapsed/refractory multiple myeloma |
| N21399 | Iressa (gefitinib) | AstraZeneca | 5/5/2003 | Treatment of non-small cell lung cancer |
| BL125058 | Aldurazyme (laronidase) | Biomarin Pharm | 4/30/2003 | Treatment of patients with Hurler and Hurler-Scheie forms of Mucopolysacchar- idosis I (MPS I) and for patients with the Scheie form who have moderate to severe symptoms |
| BL103979 | Fabrazyme (agalsidase beta) | Genzyme Corporation | 4/24/2003 | Use in patients with Fabry disease to reduce globo- triaosylceramide (GL-3) deposition in capillary endothelium of the kidney and certain other cell types |
| N21106 | Somavert (pegvisomant) | Pharmacia and Upjohn | 3/25/2003 | Treatment of acromegaly |
| N21481 | Fuzeon (enfuvirtide) | Hoffmann-La Roche | 3/13/2003 | Treatment of HIV |
| BL103964 5000 | Pegasys (peginterferon alfa-2a) | Hoffmann-La Roche | 12/3/2002 | PEGASYS, peginterferon alfa-2a, alone or in combination with COPEGUS, for the treatment of adults with chronic hepatitis C virus infection who have compensated liver disease and have not been previously treated with interferon alpha |
| N20541 SE1-010 | Arimidex (anastrozole) | AstraZeneca | 9/5/2002 | Adjuvant treatment of early breast cancer in postmenopausal women |
| N21492 | Eloxatin (oxaliplatin) | Sanofi- Synthelabo | 8/9/2002 | Treatment of colorectal cancer |
| BL125019 | Zevalin (ibritumomab tiuxetan) | IDEC Pharms | 2/19/2002 | Treatment of patients with relapsed or refractory low-grade, follicular, or transformed B-cell non-Hodgkin's lymphoma: (not acc. app.) including patients with Rituximab (Rituxan) refractory follicular non-Hodgkin's lymphoma |
| N21232 | Orfadin (nitisinone) | Swedish Orphan | 1/18/2002 | Treatment of hereditary tyrosinemia type I |
| N21356 | Viread (tenofovir disoproxil fumarate) | Gilead | 10/26/2001 | Treatment of HIV |
| N21335 | Gleevec (imatinib mesylate) | Novartis Pharms | 5/10/2001 | Treatment of Chronic Myeloid Leukemia |
| BL103948 | Campath (alemtuzumab) | ILEX Pharms | 5/7/2001 | Treatment of B-cell chronic lymphocytic leukemia (B-CLL) in patients who have been treated with alkylating agents and who have failed fludarabine therapy |
| N21227 | Candidas (caspofungin acetate) | Merck | 1/26/2001 | Treatment of aspergillus infections for patients who are refractory to or intolerant of other therapies |
| BL103772 1007.0 | Remicade (infliximab) | Centocor | 12/29/2000 | Expand the indication to include the inhibition of progression of structural damage in patients with rheumatoid arthritis who have had an inadequate response to methotrexate |
| N21248 | Trisenox (arsenic trioxide) | Cell Therapeutics | 9/25/2000 | Treatment of acute promyelocytic leukemia |
| N21226 | Kaletra (lopinavir/ritonavir) Capsules | Abbott Labs | 9/15/2000 | Treatment of HIV |
| N21251 | Kaletra (lopinavir/ritonavir) Oral Solution | Abbott Labs | 9/15/2000 | Treatment of HIV |
| BL103836 1001.0 | Actimmune (interferon gamma-1b) | InterMune | 2/10/2000 | Delaying time to disease progression in patients with severe, malignant osteopetrosis |
| N20449 SE1-011 | Taxotere (docetaxel) | Aventis Pharms | 12/23/1999 | For the treatment of locally advanced or metastatic non-small cell lung cancer |
| N21007 | Agenerase (amprenavir) Capsules | Glaxo Wellcome | 4/15/1999 | Treatment of HIV |
| N21039 | Agenerase (amprenavir) Oral Solution | Glaxo Wellcome | 4/15/1999 | Treatment of HIV |
| N20978 | Ziagen (abacavir sulfate) Oral Solution | Glaxo Wellcome | 12/17/1998 | Treatment of HIV |
| N20977 | Ziagen (abacavir sulfate) Tablets | Glaxo Wellcome | 12/17/1998 | Treatment of HIV |
| BL103795 | Enbrel (etanercept) | Immunex | 10/2/1998 | Treatment of rhuematoid arthritis |
| BL103792 | Herceptin (trastuzumab) | Genentech | 9/25/1998 | Treatment of metastatic breast cancer |
| N020972 | Sustiva (efavirenz) | DuPont Pharms | 9/17/1998 | Treatment of HIV |
SOURCE CDER Fast Track Products Approved Since 1998 through 9/30/06 FDA Online Publication 2006
