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BY OUR PHARMA CORRESPONDENT
July 14, 2005: AIDS drug zidovudine, manufactured by Ranbaxy has received the US FDA's tentative approval. The product by Ranbaxy contains 300 mg of zidovudine in each tablet. This is also the first generic version of the Retrovir brand of zidovudine made by GlaxoSmithKline. The tentative US DA approval means that this Ranbaxy product will now be considered for buying and use outside the US under the US President's Emergency Plan for AIDS Relief(PEPFAR).
Says Murray M. Lumpkin, M.D., Acting Deputy Commissioner (International andSpecial Programs) at the FDA: "This action today by HHS/FDA adds yet another valuable product to the growing list of effective and safe quality medicines available for consideration for purchase under the President's Emergency Plan. We are especially appreciative of
HHS/FDA's Office of Generic Drugs for the exceptional work they continue to do to help assure that patients this program serves receive medications they can trust and that can indeed help improve the quality of their lives."
The FDA tentative nod in effect means that though existing patents block selling this in US, it meets all FDA conditions on quality, safety and efficacy standards for selling in US.
PEPFAR was was announced by US president George Bush in 2003. The program is now providing $15 billion to combat HIV/AIDS over a period of five years, with particular attention on 15 of the worst-hit nations. PEPFAR hopes to prevent 7 million new AIDS cases, treat at least two million
HIV-infected people, and take care of ten million HIV-affected individuals, AIDS orphans and vulnerable children.
PEPFAR has its focus on three specific areas related to
HIV/AIDS: First, Prevention of HIV transmission; second, treatment of AIDS and associated conditions; three, care, including palliative care for HIV infected-individuals, and care for orphans
and vulnerable children.
Zidovudine comes under the class of drugs called nucleoside reverse transcriptase inhibitors (NRTIs), which help keep the AIDS virus from reproducing. This anti-retroviral drug is intended to be used with other anti-retroviral agents for the treatment of HIV-1 infection.
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