|
NDA or BLA # |
Proprietary Name (Established or Proper
Name) |
Applicant |
Approval Date |
Use |
| N22059 |
Tykerb (lapatinib ditosylate) |
GlaxoSmithKline |
3/13/2007 |
Treatment-refractory
(including Herceptin) advanced or metastatic ErbB2-overexpressing breast
cancer |
| N22041 |
Cyanokit (hydroxocobalamin) |
EMD |
12/15/2006 |
For the treatment of
known or suspected cyanide poisoning |
| BL103772 5145 |
Remicade (infliximab) |
Centocor |
10/13/2006 |
Maintenance of clinical
remission and mucosal healing in the treatment of patients with moderately
to severely active ulcerative coliltis (UC), who have had an inadequate
response to conventional therapy |
| N21991 |
Zolinza (vorinostat) |
Merck |
10/6/2006 |
Treatment of cutaneous
T-cell lymphoma |
| 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 (dasatinib) |
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 |
|
|
|
|
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