Mylan receives tentative FDA approval of ANDA for generic Allegra

By Lisa Kerner

Erie, Pa., April 12 - Mylan Laboratories, Inc. said the Food and Drug Administration has granted tentative approval for the company's Abbreviated New Drug Application for fexofenadine hydrochloride tablets, 30mg, 60mg and 180mg, the AB-rated generic equivalent of Aventis Pharmaceuticals' Allegra tablets.

According to IMS Health, Allegra had U.S. sales of approximately $1.4 billion as of December 31.

Mylan and its subsidiaries develop, license, manufacture, market and distribute generic and proprietary products. The company is based in Pittsburgh.

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