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HYDERABAD, India — The Food and Drug Administration has approved Dr. Reddy's version of an allergy medication that recently received Rx-to-OTC switch approval, the generic drug maker said.
Dr. Reddy's fexofenadine HCl tablets are bioequivalent versions of Sanofi-Aventis’ Allegra, which received Rx-to-OTC switch approval from the FDA in January.
The fexofenadine HCl Rx market had branded and generic sales of approximately $452 million for the 12 months ended last December, according to IMS Health.