Cipla Receives Tentative FDA Approval To Produce Oral Form Of Generic Antiretroviral Lamivudine For PEPFAR

Main Category: HIV / AIDS
Article Date: 30 Jun 2006 - 16:00 PDT

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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).

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