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CDER New Molecular Entity (NME) Drug and New
Biologic Approvals in Calendar Year 2008
Updated through February 29, 2008
NME New Drug Application (NDA) Approvals:
| NDA Number |
Proprietary Name |
Established Name |
Applicant |
Review Classification |
Approval Date |
Indication |
N022187 |
Intelence |
etravirine |
Tibotec |
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. |
| N021992 |
Pristiq |
desvenlafaxine succinate |
Wyeth |
S |
29-Feb-08 |
Provides treatment of major depressive disorder. |
New 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-2008 |
Provides treatment for cryopyrin-associated periodic syndromes (CAPS). |
Therapeutic Potentials:
P
- Priority Review - Significant improvement
compared to marketed products, in the treatment, diagnosis, or
prevention of a disease.
S - Standard Review - The drug appears to have therapeutic
qualities similar to those of one or more already marketed
drugs.
O - Orphan
Designation - Pursuant to Section 526 of the Orphan Drug Act (Public Law 97-414 as amended).
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Last Updated: March 13, 2008 |
