GSK Retrovir Goes Generic
This article was originally published in The Pink Sheet Daily
Executive Summary
Zidovudine ANDAs from Ranbaxy, Roxane and Aurobindo are the first generic pediatric AIDS drugs approved for the U.S. market.
|
FDA has approved three generic versions of GlaxoSmithKline's antiretroviral Retrovir , the agency announced Sept. 19. In a release, the agency said that zidovudine is the first generic pediatric AIDS drug to be available in the United States. Following expiration of Retrovir's patent Sept. 17, FDA approved ANDAs for tablets manufactured by Ranbaxy and Boehringer Ingelheim's Roxane Labs, as well as tablets and oral solution by Aurobindo Pharma. The generics of the nucleoside reverse transcriptase inhibitor had been tentatively approved in the U.S. under President Bush's Emergency Plan for AIDS Relief (PEPFAR), which allows generic products that meet FDA standards to be made available for purchase outside the U.S. Care for "vulnerable children" is one of the key principles of PEPFAR. A report released by the Government Accountability Office in January said that patent exclusivity was a barrier to PEPFAR procurement of generic AIDS drugs in the U.S. (1 (Also see "U.S. Patents Could Limit President's AIDS Drug Assistance Plan, GAO Says" - Pink Sheet, 28 Jan, 2005.)). Total annual sales for zidovudine tablets and oral solution are approximately $62 mil., Ranbaxy said in a Sept. 20 release announcing the approval. Ranbaxy said that it is prepared for an immediate launch of zidovudine. - Kathleen Michael |