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CDER
New Molecular Entity (NME) Drug and New Biologic Approvals in Calendar Year 2004
Updated
through September 30, 2004
NME New Drug Application (NDA)
Approvals:
| NDA Number |
Proprietary
Name |
Established
Name |
Applicant |
Chemical
Type |
Review
Classification |
Approval
Date |
|
N021395 |
Spiriva
Handihaler |
Tiotropium
Bromide |
Boehringer
Ingelheim |
1 |
S |
30-Jan-04 |
|
N021462 |
Alimta |
Pemetrexed
Disodium |
Eli
Lilly |
1 |
P, O |
04-Feb-04 |
|
N021688 |
Sensipar |
Cinacalcet
Hydrochloride |
Amgen |
1 |
P |
08-Mar-04 |
|
N021144 |
Ketek |
Telithromycin |
Aventis
Pharms |
1 |
S |
01-Apr-04 |
|
N021256 |
Human
Secretin |
Human
Secretin |
Chirhoclin |
1 |
P, O |
09-Apr-04 |
|
N021629 |
Apidra |
Insulin
Glulisine |
Aventis
Pharms |
1 |
S |
16-Apr-04 |
|
N021264 |
Apokyn |
Apomorphine
Hydrochloride |
Bertek |
1 |
P |
20-Apr-04 |
|
N021618 |
Tindamax |
Tinidazole |
Presutti Labs |
1 |
S, O |
17-May-04 |
|
N050794 |
Vidaza |
Azacitidine |
Pharmion |
1 |
P, O |
19-May-04 |
|
N021361 |
Xifaxan |
Rifaximin |
Salix Pharma |
1 |
S |
25-May-04 |
|
N021595 |
Sanctura |
Trospium Chloride |
Indevus |
1 |
S |
28-May-04 |
|
N021667 |
NutreStore |
L-Glutamine |
Nutritional
Restart |
1 |
S, O |
10-Jun-04 |
|
N021431 |
Campral |
Acamprosate Calcium |
Lipha |
1 |
P |
29-Jul-04 |
| N021427 |
Cymbalta |
Duloxetine
Hydrochloride |
Eli
Lilly |
1 |
S |
03-Aug-04 |
| N021751 |
Pentetate Zinc
Trisodium |
Pentetate Zinc
Trisodium |
Pharma Hameln
GmbH |
1 |
P |
11-Aug-04 |
| N021749 |
Pentetate Calcium
Trisodium |
Pentetate Calcium
Trisodium |
Pharma Hameln
GmbH |
1 |
P |
11-Aug-04 |
New Biologic License Application
(BLA) Approvals:
|
BLA Number |
Proprietary
Name |
Proper Name |
Applicant |
Review Classification |
Approval
Date |
|
BL125084 |
Erbitux |
Cetuximab |
ImClone Systems |
P |
12-Feb-04 |
|
BL125085 |
Avastin |
Bevacizumab |
Genentech |
P |
26-Feb-04 |
|
BL103928 |
NeutroSpec |
Technetium
99m Tc Fanolesomab |
Palatin
Technologies |
S |
02-Jul-04 |
NDA
Chemical Type:
1 - New molecular entity
Review Classification:
P - Priority Review - Significant
improvement compared to marketed products, in the treatment,
diagnosis, or prevention of a disease.
S - Standard Review -
Products that do not qualify for priority review.
O - Orphan Designation - Pursuant to
Section 526 of the Orphan Drug Act (Public Law 97-414 as amended).
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Date created: March 5, 2004; updated
October 25, 2004
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