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

 

   
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 links to other Internet sites should not be construed as an endorsement of the views contained therein.
Copyright Information | Privacy | FOIA