FDA OKS NEW GENERIC HIV DRUG FOR OVERSEAS MARKETING

Published Online: Saturday, July 1, 2006
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The FDA has granted tentative approval for generic abacavir sulfate tablets—the first generic version of Glaxo- SmithKline's Ziagen anti-HIV medication. The generic product will be manufactured by Aurobindo Pharma Ltd of Hyderabad, India, and will be available for consideration for purchase under the President's Emergency Plan for AIDS Relief.

The FDA'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. Although existing patents preclude marketing the new generic in the United States, the drug can be sold abroad and used under the President's plan.




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