Appendix VI: Generic HIV/AIDS Formulations Made Eligible for Purchase by PEPFAR Programs under the HHS/FDA Expedited Review Process, Through December 10, 2006


(http://www.fda.gov/oia/pepfar.htm)

Drug Company Date of FDA Approval or Tentative Approval
Didanosine (200mg, 250mg, 400mg delayed release capsules ) Barr Laboratories Approved 12/03/04
Zidovudine (300mg)/lamivudine (150mg) tablets co-packaged with Nevirapine (200mg) Aspen Pharmacare Tentatively Approved 1/25/05
Lamivudine (150mg and 300mg tablets) Aurobindo Pharma Tentatively Approved 6/15/05
Lamivudine (150mg tablets) Ranbaxy Laboratories Tentatively Approved 5/27/05
Nevirapine (200mg tablets) Ranbaxy Laboratories Tentatively Approved 6/20/05
Nevirapine (200mg tablets) Aurobindo Pharma Tentatively Approved 6/20/05
Efavirenz (600mg tablets) Aurobindo Pharma Tentatively Approved 6/24/05
Stavudine (30mg and 40mg capsules) Aurobindo Pharma Tentatively Approved 7/1/05
Lamivudine (150mg)/Zidovudine (300mg) tablets Aurobindo Pharma Tentatively Approved 7/7/05
Zidovudine (300mg tablets) Ranbaxy Laboratories Tentatively Approved 7/13/05;
Approved 9/19/05
Zidovudine (300mg tablets) Aurobindo Pharma Tentatively Approved 8/25/05;
Approved 9/19/05
Zidovudine (oral solution 50mg/5ml) Aurobindo Pharma Tentatively Approved 9/7/05;
Approved 9/19/05
Lamivudine (10mg/ml oral solution) Aurobindo Pharma Tentatively Approved 11/8/05
Stavudine (oral solution 1mg/mL) Aurobindo Pharma Tentatively Approved 12/21/05
Nevirapine (oral suspension 50 mg/5 mL) Aurobindo Pharma Tentatively Approved 12/27/05
Lamivudine (150mg)/Zidovudine (300mg) tablets
co-packaged with Efavirenz (600mg)
Aurobindo Pharma Tentatively Approved 3/6/06
Zidovudine (100mg capsules) Aurobindo Pharma Approved 3/27/06
Abacavir (300mg tablets) Aurobindo Pharma Tentatively Approved 5/17/06
Nevirapine (200mg tablets) Cipla Limited Tentatively Approved 5/19/06
Efavirenz (600mg tablets) Cipla Limited Tentatively Approved 5/24/06
Lamivudine (10mg/ml oral solution) Cipla Limited Tentatively Approved 6/22/06
Abacavir (20mg/ml oral solution) Aurobindo Pharma Tentatively Approved 6/27/06
Stavudine (15mg and 20mg capsules) Aurobindo Pharma Tentatively Approved 6/27/06
Lamivudine (150mg)/Zidovudine (300mg)/Nevirapine (200mg) tablets Aurobindo Pharma Tentatively Approved 6/30/06
Didanosine (100mg, 150 mg, 200 mg) chewable tablets Aurobindo Pharma Tentatively Approved 7/10/06
Lamivudine (150mg)/Zidovudine (300mg) tablets
co-packaged with Abacavir (300mg) tablets
Aurobindo Pharma Tentatively Approved 7/26/06
Nevirapine (200mg) tablets Strides Arcolabs Tentatively Approved 8/11/06
Lamivudine (150mg)/Zidovudine (300mg tablets) Pharmacare Limited Tentatively Approved 8/23/06
Stavudine (30mg and 40mg tablets) Strides Arcolabs Tentatively Approved 8/28/06
Lamivudine (150mg)/Zidovudine (300mg) tablets Cipla Limited Tentatively Approved 9/13/06
Didanosine (10mg/ml oral solution) Aurobindo Pharma Tentatively Approved 10/05/06
Abacavir (300mg tablets) Cipla Limited Tentatively Approved 11/06/06
Lamivudine (150mg)/Stavudine (30mg and 40mg)/Nevirapine 200mg) tablets Cipla Limited Tentatively Approved 11/17/06

 

Back to Top

USA.gov U.S. Government interagency website managed by the Office of U.S. Global AIDS Coordinator
and the Bureau of Public Affairs, U.S. State Department.
External Link Policy | Copyright Information | Privacy | FOIA