FDA Grants Cipla Tentative Approval To Produce Generic Pediatric Antiretroviral for PEPFAR
Indian drug maker Cipla on Monday received tentative FDA approval for use of its generic, combination antiretroviral drug for children in the President's Emergency Plan for AIDS Relief, Reuters reports. According to Reuters, the drug -- a combination of nevirapine, lamivudine and stavudine -- is the first combination therapy that will be available for children ages 12 and younger under PEPFAR.
According to FDA officials, the combination drug is a major advance because it can be stored, distributed and administered easily to children. The pill also can be swallowed or dissolved in water, Reuters reports. The generic drug cannot be sold in the U.S. because some of its components are protected by patents, according to Reuters. FDA on Monday also announced that it has given tentative approval to Indian drug maker Hetero Drugs for use of its generic nevirapine tablets in PEPFAR (Richwine, Reuters, 8/13).