Friday, November 24, 2006

Fast Track New Drug Application Tentative Approvals for HIVs

Fast Track New Drug Application Tentative Approvals under the President's Emergency Plan for AIDS Relief (PEPFAR):

lamivudine 150mg; zidovudine 300mg Fixed-Dose Tablets Pharmacare 8/23/2006*

lamivudine 150mg; zidovudine 300mg Fixed-Dose Tablets Co-Packaged with abacavir 300mg tablets Aurobindo 7/26/2006*

lamivudine 150mg; zidovudine 300 mg; nevirapine 200mg Fixed-Dose Tablets Aurobindo
6/30/2006*

lamivudine 150mg zidovudine 300mg Fixed-Dose Tablets co-packaged with efavirenz 600mg tablets Aurobindo 3/6/2006*

lamivudine 150mg; zidovudine 300mg tablets co-packaged with nevirapine 200mg tablets
Aspen Pharmacare 1/24/2005*