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FDA approves generic version of Videx

FDA approves generic version of Videx

The Food and Drug Administration on Friday approved a generic version of the antiretroviral medication Videx EC (ddI) made by Woodcliff, N.J.-based Barr Laboratories for use in developing countries. Videx EC is sold in the United States by Bristol-Myers Squibb. Barr Laboratories submitted applications with the FDA to manufacture, market, and sell the generic version of the drug in 200-milligram, 250-milligram, and 400-milligram capsules. Barr plans to launch the generic drugs immediately and make them available for purchase through the President's Emergency Plan for AIDS Relief, which focuses on HIV prevention and treatment in 15 developing countries. "We applaud the FDA for expediting the review for this important medicine in the fight against AIDS, which allows us to bring a more cost-effective version of this therapy to patients who need it sooner than would have otherwise been possible," said Barr Laboratories chairman and CEO Bruce Downey.

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