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Credit First Service Union The FDA and HHS said they have tentatively approved an India pharmeceutical manufacturer's generic AIDS drug.If you would like to receive late breaking news on health issues covered by AXcess News then you need to subscribe.

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Card Credit Discover Service July 13, 2005 (AXcess News) Washington - The FDA and HHS said they have tentatively approved an India pharmeceutical manufacturer's generic AIDS drug. The drug is a combination of lamivudine and zidovudine in tablet form manufactured by Aurobindo Pharma Ltd. of Hyderabad, India

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Credit Public Service Union This fixed-dose combination product contains 150 milligrams of lamivudine and 300 mg of zidovudine in each tablet, and is the first generic version of the already-approved Combivir brand of the product manufactured by GlaxoSmithKline (NYSE: GSK). Because of the tentative approval by HHS/ FDA, this Aurobindo generic product will now be available for consideration for purchase and use outside the United States under the President's Emergency Plan for AIDS Relief.Health and Human Services Secretary Mike Leavitt told the media, "FDA's action underscores our Department's continuing commitment to the patients being served by President Bush's Emergency Plan. We are extremely pleased to have the first generic lamivudine/zidovudine fixed-dose combination product now available for consideration for use in our efforts to make quality AIDS treatments available to patients in the countries aided by the President's Emergency Plan."The Emergency Plan for AIDS Relief, which President Bush first announced in his 2003 State of the Union Address, is currently providing $15 billion to fight the HIV/AIDS pandemic over five years, with a special focus on 15 of the hardest-hit countries. The President's Emergency Plan is designed to prevent seven million new HIV infections, treat at least two million HIV-infected people, and care for ten million HIV-affected individuals, AIDS orphans and vulnerable children.Lamivudine and zidovudine are in the class of drugs called nucleoside reverse transcriptase inhibitors (NRTIs), which help keep the AIDS virus from reproducing. This fixed-dose combination anti-retroviral drug is intended to be used with other antiretroviral agents for the treatment of HIV-1 infection.Source: US Food and Drug Administration

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