Ranbaxy Receives Tentative FDA Approval to Produce Generic Version of Antiretroviral Retrovir for PEPFAR

FDA on Wednesday granted tentative approval to Indian generic drug manufacturer Ranbaxy Laboratories to produce the antiretroviral drug zidovudine for inclusion in the President's Emergency Plan for AIDS Relief, the Newark Star-Ledger reports. The tentative approval represents the first for zidovudine, which is sold by GlaxoSmithKline under the brand name Retrovir (Jordan, Newark Star-Ledger, 7/14). HHS in May 2004 announced plans for an FDA fast-track review program to speed the delivery of low-cost antiretrovirals -- including fixed-dose combination drugs -- to nations covered under PEPFAR. The expedited process is meant to encourage drug makers to produce generic medications to improve access to drugs in remote areas of severely affected countries and ensure the drugs' safety. The tentative approval designation means the generic 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, 7/11). However, the tentative approval will allow Ranbaxy to sell zidovudine in the U.S. when GSK's patent expires in two years (Howard Price, Washington Times, 7/14).

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