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FDA Approves Aurobindo Pharma's HIV drug

The Food and Drug Administration grants tentative approval of generic abacavir sulfate tablets to treat HIV. The drug is the first generic version of Ziagen Tablets, an anti-HIV medication already approved by the FDA.

Aurobindo Pharma LTD. of Hyderabad, India manufactures the generic version, which will now be available for consideration of purchase under the President's Emergency Plan for AIDS Relief. President Bush introducted the President's Emergency Plan for AIDS Relief in his 2003 State of the Union Address. It provides $15 billion to fight HIV/AIDS over five years, and focuses on 15 of the hardest hit countries.The agency's tentative approval of this product means that Aurobindo's product meets all of the FDA's manufacturing quality and clinical safety and efficacy standards. However, existing patents and/or exclusivity prevent its marketing in the United States.
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