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Generic AIDS drugs.

The U.S. Food and Drug Administration has tentatively approved generic versions of three AIDS drugs under the President's Emergency Plan for AIDS Relief, according to an FDA statement.

Two applications for generic versions of Viramune (nevirapine) and one each for generic versions of Retrovir (zidovudine) and Sustiva (efavirenz) were granted the tentative approval. This means that although existing patents and/or exclusivity prevent marketing in the United States, the products meet FDA quality, safety, and efficacy standards and are eligible for purchase and use outside the United States.

The President's Emergency Plan for AIDS Relief is providing $15 billion in the fight against HIV and AIDS, particularly in the hardest-hit countries. These tentative drug approvals aim to make safe, effective treatment available through the Plan as quickly as possible, according to the FDA.
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Title Annotation:CLINICAL CAPSULES; approval for AIDS drugs
Author:Worcester, Sharon
Publication:Internal Medicine News
Article Type:Brief Article
Date:Aug 15, 2005
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