Aurobindo Pharma, Ranbaxy Receive Tentative FDA Approval To Produce Generic Antiretroviral Nevirapine for PEPFAR
FDA on Monday granted tentative approval to Indian drug manufacturers Aurobindo Pharma and Ranbaxy Laboratories to produce two versions of the antiretroviral drug nevirapine, qualifying the drug to be included in the President's Emergency Plan for AIDS Relief, the AP/San Francisco Chronicle reports (AP/San Francisco Chronicle, 6/20). 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 generic medications to improve access to drugs in remote areas of severely affected countries and ensure the drugs' safety (Kaiser Daily HIV/AIDS Report, 6/17). Under tentative approval, the generic drugs cannot be marketed in the United States (FDA release, 6/20). Nevirapine -- sold under the brand name Viramune by Boehringer Ingelheim -- often is used to prevent mother-to-child HIV transmission. Some research using nevirapine in pregnant women has raised controversy (Reuters, 6/20). However, despite shortcomings in an NIH-funded study of nevirapine among pregnant women in Uganda that began in 1997, there was no evidence of serious flaws that would cast doubt on the study's findings that the drug is a safe and effective treatment to reduce the risk of vertical HIV transmission, according to a report released in April by an independent review panel of the Institute of Medicine (Kaiser Daily HIV/AIDS Report, 4/8).
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