The FDA granted Mylan Laboratories tentative approval for its abbreviated new drug application for fexofenadine hydrochloride and pseudoephedrine hydrochloride extended-release tablets in 60 mg and 120 mg doses. The tablets are the generic equivalent of Aventis Pharmaceuticals' Allegra-D extended-release tablets for the treatment of allergic rhinitis.
According to Aventis Pharmaceuticals, the number of U.S. cases of allergic rhinitis is expected to climb to more than 64 million by 2011.
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