New Drug Application (NDA) Tentative Approvals under the President's Emergency Plan for AIDS Relief (PEPFAR):
NDA Number |
Proprietary Name |
Established Name |
Applicant |
Chemical Type |
Review Classification |
505(b)(2) |
Approval Date |
NO21837 |
Stavudine;Lamivudine;Nevirapine |
stavudine;lamivudine;nevirapine |
Strides |
4 |
P |
Y |
20-Mar-2008 |
NO22177 |
Stavudine;Lamivudine;Nevirapine |
stavudine;lamivudine;nevirapine |
Strides |
4 |
P |
Y |
20-Mar-2008 |
NO22167 |
Lamivudine;Stavudine |
Lamivudine;Stavudine |
Cipla Limited |
3 |
P |
Y |
19-Jun-2008 |
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.
Biologic License Application (BLA) Approvals:
BLA Number |
Proprietary Name |
Proper Name |
Applicant |
Review Classification |
Approval Date |
125249 |
Arcalyst |
rilonacept |
Regeneron |
P,O |
27-Feb-2008 |
125160 |
Cimzia |
certolizumab pegol |
CB |
S |
22-Apr-2008 |
NDA Chemical Type:
1 - New molecular entity
2 - New ester, new salt, or other noncovalent derivative
3 - New dosage form
4 - New combination
5 - New formulation or new manufacturer
7 - Drug already marketed, but without an approved NDA
8 - OTC switch
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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Last updated: July 24, 2008