FDA Notifications

Tentative approval of India-made ziovudine

The Food and Drug Administration announced in July the tentative approval of zidovudine tablets manufactured by Ranbaxy Laboratories Ltd. of Guragon, India. The product contains 300 mg zidovudine in each tablet. It is a generic version of the already-approved Retrovir brand of the product manufactured by GlaxoSmithKline.

Tentative approval means that although existing patents and/or exclusivity prevent marketing of this product in the United States, it meets the quality, safety, and efficacy standards for U.S. marketing.

Tentative approval by FDA makes this Ranbaxy generic product eligible for purchase and use outside the United States under the President’s Emergency Plan for AIDS Relief.