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Pharma company files application with FDA for antiretroviral agent.
2004 DEC 1 - (NewsRx.com & NewsRx.net) -- Ranbaxy Inc., a wholly owned subsidiary of Ranbaxy Laboratories Limited (RLL), announced that RLL had filed an ANDA with the U.S. Food and Drug Administration (FDA) for Zidovudine Tablets, 300 mg.
This is the first of a series of antiretroviral (ARV) ANDA filings by RLL that are anticipated in the near term that will be supportive of the President's Emergency Plan for AIDS Relief (PEPFAR) initiative.
As is customary, RLL will generate and provide appropriate scientific data supporting the efficacy of Zidovudine tablets in order to allow the FDA to technically review the formulation and grant final approval. With FDA approval, the formulation can then be employed to manage patients afflicted with AIDS in PEPFAR identified countries, when mutually acceptable procurement terms are agreed upon.
RLL is committed to supporting PEPFAR by providing antiretroviral agents that successfully pass regulatory scrutiny, and remain committed and dedicated as well, to supporting the ...
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