PRINCETON, N.J. (AP) - Ranbaxy Pharmaceuticals Inc., the U.S. unit of Indian drug maker Ranbaxy Laboratories Ltd., said Wednesday it received tentative approval from the Food and Drug Administration to market a generic version of allergy medication Allegra.
The tentative approval covers 30-milligram, 60-milligram, and 180-milligram tablets of fexofenadine hydrochloride, the active ingredient in Sanofi-Aventis AS's Allegra.
Tentative approval from the FDA is given when a generic drug maker's marketing application is in order but patent or legal issues prevent the agency from issuing final approval.
Patents protecting Allegra begin to expire in May 2012.
Barr Pharmaceuticals Inc. and Teva Pharmaceutical Industries Ltd., who already sell a generic version of Allegra, went a different regulatory route than Ranbaxy, and were sued by Sanofi-Aventis.
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