|
NDA BLA # |
Product |
Sponsor
Applicant |
Div |
Clock Date |
Approval Date |
IND # |
IND Drug Name |
Fast Track
Request Date |
Date Fast Track
Granted |
Use |
| N21677 |
Alimta
(pemetrexed disodium) |
Lilly |
150 |
11/4/2003 |
8/19/2004 |
I40061 |
LY231514
Disodium |
5/20/2003 |
7/23/2003 |
Treatment
of non-small cell lung cancer |
| N50794 |
Vidaza
(azacitidine) |
Pharmion |
150 |
12/29/2003 |
5/19/2004 |
I64251 |
azacitadine |
9/22/2003 |
10/10/2003 |
Treatment
of patients with certain subtypes of myelodysplastic syndrome |
| N21264 |
Apokyn
(apomorphine) |
Bertek |
120 |
4/18/2000 |
4/20/2004 |
I52844 |
apomorphine
hydrochloride injection |
10/26/1998 |
6/27/2001 |
Treatment
of acute, intermittent hypomobility, "off" episodes
("end-of-dose wearing off" and unpredictable "on/off"
episodes) associated with advanced Parkinson’s disease |
| L125085 |
Avastin
(bevacizumab) |
Genentech |
ODE
6 |
9/30/2003 |
2/26/2004 |
7023 |
Bevacuzumab
[Humanized Monoclonal Antibody (rhuMAb VEGF) to the vascular Endothelial
Growth Factor] and Chemotherapy |
6/9/2003 |
7/26/2003 |
For
the first-line treatment of patients with metastatic carcinoma of the colon
and rectum (in combination with intravenous 5-fluorouracil-based
chemotherapy) |
| L125084 |
Erbitux
(cetuximab) |
ImClone
Systems |
ODE
6 |
8/14/2003 |
2/12/2004 |
5804 |
Cetuximab
[Chimeric Monoclonal Antibody (C225) to the Epidermal Growth Factor Receptor
(EGFR)] and Chemotherapy |
11/15/2000 |
1/12/2001 |
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 |
150 |
9/30/2003 |
2/4/2004 |
I40061 |
LY231514
Disodium |
4/11/2002 |
6/10/2002 |
Treatment
of malignant pleural mesothelioma |
| N21548 |
Lexiva
(fosamprenavir calcium) |
GlaxoSmithKline |
530 |
12/20/2002 |
10/20/2003 |
I58627 |
GW433908
Tabs |
10/12/1999 |
12/1/1999 |
Treatment
of HIV |
| N21348 |
Zavesca
(miglustat) |
Actelion
Pharms |
510 |
8/21/2001 |
7/31/2003 |
I60197 |
Zavesca |
4/24/2000 |
6/15/2000 |
Treatment
of type I Gaucher disease |
| N21500 |
Emtriva
(emtricitabine) |
Gilead |
530 |
9/3/2002 |
7/2/2003 |
I53971 |
ZD
1839 |
8/7/1998 |
9/25/1998 |
Treatment
of HIV |
| L125011 |
Bexxar
(tositumomab and iodine I 131 tositumomab) |
Corixa
Corporation |
ODE
6 |
9/15/2000 |
6/27/2003 |
3323 |
Tositumomab,
Iodine I 131 Tositumomab (Bexxar, Corixa) [Iodine-I-131 Cojugated Murine
Monoclonal Antibody (B1) Against B Lymphocytes (CD20)] |
10/1/1998 |
11/25/1998 |
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 |
150 |
1/21/2003 |
5/13/2003 |
I56515 |
Velcade
(for injection) |
1/28/2002 |
5/24/2002 |
Treatment
of relapsed/refractory multiple myeloma |
| N21399 |
Iressa
(gefitinib) |
AstraZeneca |
150 |
8/5/2002 |
5/5/2003 |
I54576 |
ZD
1839 |
8/24/1999 |
10/21/1999 |
Treatment
of non-small cell lung cancer |
| L125058 |
Aldurazyme
(laronidase) |
Biomarin
Pharm |
ODE
6 |
7/29/2002 |
4/30/2003 |
7334 |
Alpha-L-
iduronidase (human, recombninant) |
7/27/1998 |
9/25/1998 |
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 |
| L103979 |
Fabrazyme
(agalsidase beta) |
Genzyme
Corporation |
ODE
6 |
6/23/2000 |
4/24/2003 |
7616 |
Alpha-
Galactosidase A (Human, reconmbinant) |
3/10/1998 |
5/8/1998 |
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 |
510 |
12/26/2000 |
3/25/2003 |
I52850 |
B2036-PEG |
1/19/1999 |
3/18/1999 |
Treatment
of acromegaly |
| N21481 |
Fuzeon
(enfuvirtide) |
Hoffmann-La
Roche |
530 |
9/16/2002 |
3/13/2003 |
I51692 |
T-20 |
11/20/1998 |
1/7/1999 |
Treatment
of HIV |
| L103964 5000 |
Pegasys
(peginterferon alfa-2a) |
Hoffmann-La
Roche |
ODE
6 |
6/3/2002 |
12/3/2002 |
7823 |
Pegylated
Interferon alfa-2a (human, recombinant, E.coli) and Ribavirin |
6/27/2000 |
8/9/2000 |
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 |
150 |
3/5/2002 |
9/5/2002 |
- |
- |
12/21/2001 |
12/21/2001 |
Adjuvant
treatment of early breast cancer in postmenopausal women |
| N21492 |
Eloxatin
(oxaliplatin) |
Sanofi-
Synthelabo |
150 |
6/24/2002 |
8/9/2002 |
I41817 |
Oxaliplatin |
4/12/2002 |
5/10/2002 |
Treatment
of colorectal cancer |
| L125019 |
Zevalin
(ibritumomab tiuxetan) |
IDEC
Pharms |
ODE
6 |
11/1/2000 |
2/19/2002 |
4850 |
Ibritumomab
tiuxetan [Indium-IN-111 Radiolabeled and Yttrium-Y-90 Radiolabeled Murine
Monoclonal Antibody (2B8-MX-DTPA) to CD20]; Bone Marrow and G-CSF |
4/5/2000 |
6/5/2000 |
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 |
510 |
9/8/2000 |
1/18/2002 |
I46865 |
NTBC |
5/24/1999 |
7/7/1999 |
Treatment
of hereditary tyrosinemia type I |
| N21356 |
Viread
(tenofovir disoproxil fumarate) |
Gilead |
530 |
5/1/2001 |
10/26/2001 |
I52849 |
PMPA |
10/24/2000 |
11/7/2000 |
Treatment
of HIV |
| N21335 |
Gleevec
(imatinib mesylate) |
Novartis
Pharms |
150 |
2/27/2001 |
5/10/2001 |
I55666 |
CGP
57148B Oral Caps |
5/25/1999 |
7/14/1999 |
Treatment
of Chronic Myeloid Leukemia |
| L103948 |
Campath
(alemtuzumab) |
ILEX
Pharms |
ODE
6 |
12/23/1999 |
5/7/2001 |
4294 |
Alemtuzumab
[Humanized (rat/human) Monoclonal Antibody to Human Lymphocytes and Monocytes
(CD52 antigen)] |
8/14/1998 |
10/13/1998 |
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 |
590 |
7/28/2000 |
1/26/2001 |
I48484 |
L-743,872 |
3/22/1999 |
5/27/1999 |
Treatment
of aspergillus infections for patients who are refractory to or intolerant of
other therapies |
| L103772 1007.0 |
Remicade
(infliximab) |
Centocor |
ODE
6 |
10/15/1999 |
12/29/2000 |
5947 |
Infliximab
[Chimeric (human, murine) Monoclonal Antibody (cA2) to Tumor Necrosis
Factor], Methotrexate |
9/9/1999 |
9/30/1999 |
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 |
150 |
3/28/2000 |
9/25/2000 |
I55291 |
arsenic
trioxide |
12/27/1999 |
2/25/2000 |
Treatment
of acute promyelocytic leukemia |
| N21226 |
Kaletra
(lopinavir/ritonavir) Capsules |
Abbott
Labs |
530 |
6/1/2000 |
9/15/2000 |
I51715 |
ABT-378 |
8/3/1999 |
8/19/1999 |
Treatment
of HIV |
| N21251 |
Kaletra
(lopinavir/ritonavir) Oral Solution |
Abbott
Labs |
530 |
6/1/2000 |
9/15/2000 |
I51715 |
ABT-378 |
8/3/1999 |
8/19/1999 |
Treatment
of HIV |
| L103836 1001.0 |
Actimmune
(interferon gamma-1b) |
InterMune |
ODE
6 |
8/10/1999 |
2/10/2000 |
3368 |
Recombinant
Human Interferon Gamma |
3/1/1999 |
4/27/1999 |
Delaying
time to disease progression in patients with severe, malignant osteopetrosis |
| N20449 SE1-011 |
Taxotere
(docetaxel) |
Aventis
Pharms |
150 |
6/23/1999 |
12/23/1999 |
I35555 |
Taxotere
(RP 56976-TAX264) |
12/30/1998 |
2/19/1999 |
For
the treatment of locally advanced or metastatic non-small cell lung cancer |
| N21007 |
Agenerase
(amprenavir) Capsules |
Glaxo
Wellcome |
530 |
10/16/1998 |
4/15/1999 |
I47111 |
141-W94
Capsules |
2/25/1998 |
3/18/1998 |
Treatment
of HIV |
| N21039 |
Agenerase
(amprenavir) Oral Solution |
Glaxo
Wellcome |
530 |
12/8/1998 |
4/15/1999 |
I47111 |
141-W94
Capsules |
2/25/1998 |
3/18/1998 |
Treatment
of HIV |
| N20978 |
Ziagen
(abacavir sulfate) Oral Solution |
Glaxo
Wellcome |
530 |
6/24/1998 |
12/17/1998 |
I45331 |
1592-U89
Succinate Caplets |
2/19/1998 |
3/9/1998 |
Treatment
of HIV |
| N20977 |
Ziagen
(abacavir sulfate) Tablets |
Glaxo
Wellcome |
530 |
6/24/1998 |
12/17/1998 |
I45331 |
1592-U89
Succinate Caplets |
2/19/1998 |
3/9/1998 |
Treatment
of HIV |
| L103795 |
Enbrel
(etanercept) |
Immunex |
ODE
6 |
5/8/1998 |
10/2/1998 |
5088 |
Tumor
Necrosis Factor Receptor: Fc Fusion Protein (human, recombinant, CHO cells) |
3/5/1998 |
3/9/1998 |
Treatment
of rhuematoid arthritis |
| L103792 |
Herceptin
(trastuzumab) |
Genentech |
ODE
6 |
5/4/1998 |
9/25/1998 |
4517 |
trastuzumab
[Humanized Monoclonal Antibody to p185HER2/neu] |
3/26/1998 |
3/27/1998 |
Treatment
of metastatic breast cancer |
| N020972 |
Sustiva
(efavirenz) |
DuPont
Pharms |
530 |
6/11/1998 |
9/17/1998 |
I49465 |
Sustiva
(efavirenz); DMP 266 |
5/11/1998 |
5/29/1998 |
Treatment of HIV |
|
|
