Summaries of health policy coverage from major news organizations
Ranbaxy Laboratories Receives Tentative FDA Approval To Produce Generic Antiretroviral Lamivudine for PEPFAR
FDA on Tuesday granted tentative approval to Indian generic drug manufacturer Ranbaxy Laboratories to produce a generic version of the antiretroviral drug lamivudine for inclusion in the President's Emergency Plan for AIDS Relief, Reuters reports. Ranbaxy is the first Indian drug maker to gain FDA approval to produce generic antiretrovirals for PEPFAR (Reuters, 5/31). FDA in January approved a generic version of a widely used, co-packaged antiretroviral drug regimen made by South Africa's Aspen Pharmacare. HHS in May 2004 announced plans for a new FDA fast-track review program to speed the delivery of low-cost antiretroviral drugs -- including fixed-dose combination drugs -- to nations covered under PEPFAR. The expedited process is meant to encourage drug makers to produce FDCs to improve access to drugs in remote areas in severely affected countries and ensure the drugs' safety (Kaiser Daily HIV/AIDS Report, 3/3). Ranbaxy has filed for FDA approval of four other generic antiretrovirals to be included in PEPFAR (Reuters, 5/31).
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