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Two generic HIV drugs approved for children by FDA
The US Food and Drug Administration announced this week that it has approved liquid formulations of two antiretroviral drugs, lamivudine (3TC) and abacavir, for use in the treatment of children with HIV.
The FDA granted tentative approval for abacavir oral solution, 20 mg/mL, manufactured by Aurobindo Pharma Limited Inc., India.
The FDA also granted tentative approval to generic lamivudine oral solution, 10 mg/mL, manufactured by Cipla Limited, Mumbai, India.
In addition the FDA granted tentative approval for stavudine 15 and 20 mg capsules manufactured by Aurobindo Pharma Limited Inc., of Hyderabad, India. Tentative approval was granted to the same manufacturer for generic stavudine, 30 and 40 mg capsules on July 1, 2005, and for oral solution, 1 mg/mL on December 21, 2006.
FDA's tentative approval of this product means that although existing patents and/or exclusivity prevent marketing of this product in the United States, the product meets all of FDA's safety, efficacy, and manufacturing quality standards required for marketing in the U.S. and it will now be available for consideration for purchase under the President's Emergency Plan for AIDS Relief (PEPFAR).
The FDA granted tentative approval for abacavir oral solution, 20 mg/mL, manufactured by Aurobindo Pharma Limited Inc., India.
The FDA also granted tentative approval to generic lamivudine oral solution, 10 mg/mL, manufactured by Cipla Limited, Mumbai, India.
In addition the FDA granted tentative approval for stavudine 15 and 20 mg capsules manufactured by Aurobindo Pharma Limited Inc., of Hyderabad, India. Tentative approval was granted to the same manufacturer for generic stavudine, 30 and 40 mg capsules on July 1, 2005, and for oral solution, 1 mg/mL on December 21, 2006.
FDA's tentative approval of this product means that although existing patents and/or exclusivity prevent marketing of this product in the United States, the product meets all of FDA's safety, efficacy, and manufacturing quality standards required for marketing in the U.S. and it will now be available for consideration for purchase under the President's Emergency Plan for AIDS Relief (PEPFAR).
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