Allergy Medicine

Tentative approval granted for Allegra-D extended-release tablets

Published in Medical Letter on the CDC and FDA, August 8th, 2004

Barr Pharmaceuticals, Inc., (BRL) announced that Barr Laboratories, Inc., has received tentative approval from the U.S. Food and Drug Administration (FDA) for its generic version of Aventis Pharmaceuticals' Allegra-D (Fexofenadine HCl 60mg and Pseudoephedrine HCl 120mg) Extended-Release Tablets.

The company anticipates receiving final approval and launching its generic product following the resolution of the patent challenge litigation surrounding this product.

Allegra-D is indicated for the relief of symptoms associated with seasonal allergic rhinitis in adults and children 12 years of age and older. Allegra-D had annual sales of approximately $450...

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Source: Medical Letter on the CDC and FDA (2004-08-08)

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