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CDER Priority Drug and
Biologic Approvals in Calendar Year 2008
Updated through July 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. |
| N022249 |
Treanda |
bendamustine hydrochloride |
Cephalon |
1 |
P,O |
20-Mar-08 |
Provides for the treatment of patients with chronic lymphocytic leukemia (CLL). |
| N021822 |
Aptivus |
tipranavir |
Boehringer Ingelheim |
3 |
P |
23-Jun-08 |
Provides for combination antiretroviral treatment of HIV-1 infected pediatric (age 2 to 18 years) patients who are treatment-experienced and infected with HIV-1 strains resistant to more than one protease inhibitor. |
| N022212 |
Durezol |
difluprednate |
Sirion |
1 |
P |
23-Jun-08 |
Provides for the treatment of inflammation and pain associated with ocular surgery. |
| N022292 |
Aptivus |
tipranavir |
Boehringer Ingelheim |
3 |
P |
23-Jun-08 |
Provides for combination antiretroviral treatment of HIV-1 infected pediatric (age 2 to 18 years) patients who are treatment-experienced and infected with HIV-1 strains resistant to more than one protease inhibitor. |
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 |
| NO21837 |
Stavudine;Lamivudine;Nevirapine |
stavudine;lamivudine;nevirapine |
Strides |
4 |
P |
20-Mar-08 |
Provides for the treatment of HIV-1 infection. |
| NO22177 |
Stavudine;Lamivudine;Nevirapine |
stavudine;lamivudine;nevirapine |
Strides |
4 |
P |
20-Mar-08 |
Provides for the treatment of HIV-1 infection |
| NO22167 |
Lamivudine;Stavudine |
lamivudine;stavudine |
Cipla Limited |
3 |
P |
19-Jun-08 |
Provides for the treatment of HIV-1 |
N021837 stavudine 40mg/lamivudine 150mg/nevirapine 200mg Tablets was tentatively approved on 03/20/2008 under PEPFAR.
N022177 stavudine 30mg/lamivudine 150mg/nevirapine 200mg Tablets was tentatively approved on 03/20/2008 under PEPFAR.
N022167 lamivudine 30mg/stavudine 6mg Tablets was tentatively approved on 06/19/2008 under PEPFAR.
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
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Last updated: August 15, 2008 |
