|
CDER Priority Drug and
Biologic Approvals in Calendar Year 2008
Updated through January 31, 2008
Priority New Drug Application (NDA) Approvals:
| NDA Number |
Proprietary Name |
Established Name |
Applicant |
Chemical Type |
Review Classification |
Approval Date |
Indication |
| N022187 |
Intelence |
etravirine |
Tibotec |
1 |
P |
18-Jan-08 |
Provides in combination with other antiretroviral agents for the the treatment of HIV-1 infection in treatment-experienced adult patients, who have evidence of viral replication and HIV-1 strains resistant to a non-nucleoside reverse transcriptase inhibitor (NNRTI) and other antiretroviral agents. |
| N022101 |
Nexium |
esomeprazole magnesium |
AstraZeneca |
1 |
P |
27-Feb-08 |
Provides for short-term treatment of GERD and healing of erosive esophagitis in pediatric patients aged 1-11 years. In addition, it provides a new dosing schedule for pediatric patients. |
New Drug Application (NDA) Tentative Approvals under the President's Emergency Plan for AIDS Relief (PEPFAR):
| NDA Number |
Proper Name |
Established Name |
Applicant |
Chemical Type |
Review Classification |
Approval Date |
Indication |
| There were no PEPFAR approvals for February |
Priority Biologic License Application (BLA) Approvals:
| BLA Number |
Proprietary Name |
Proper Name |
Applicant |
Review Classification |
Approval Date |
Indication |
| 125249 |
Arcalyst |
rilonacept |
Regeneron |
P,O |
27-Feb-08
|
Provides treatment for cryopyrin-associated periodic syndromes (CAPS). |
NDA Chemical Type:
1 - New molecular entity
2 - New ester, new salt, or other noncovalent derivative
3 - New formulation
4 - New combination
5 - New manufacturer
7 - Drug already marketed, but without an approved NDA
Review Classification:
P - Priority Review - Significant improvement compared to marketed products, in the treatment, diagnosis, or prevention of a disease.
O - Orphan Designation - Pursuant to Section 526 of the Orphan Drug Act (Public Law 97-414 as amended).
To access approval letters, labels, and review packages, go to
 Back
to Top 
Back to Reports
 PDF requires the free
Adobe Acrobat Reader
Last updated: March 13, 2008 |
