Cipla Receives Tentative FDA Approval To Produce Oral Form of Generic Antiretroviral Lamivudine for PEPFAR

Indian drugmaker Cipla has received tentative FDA approval to produce an oral version of the antiretroviral drug lamivudine, a generic version of GlaxoSmithKline's Epivir, under the President's Emergency Plan for AIDS Relief, India's Hindu reports (Hindu, 6/27). The tentative approval designation means the drug meets FDA safety and efficacy standards but cannot be sold in the U.S. because of existing patents or exclusivity agreements (Kaiser Daily HIV/AIDS Report, 5/31). The tentative approval allows Cipla to produce for PEPFAR an oral solution of lamivudine, which belongs to a drug class called nucleoside reverse transcriptase inhibitors, at strengths of 10mg per ml, the Hindu reports (Hindu, 6/27).