Friday, February 04, 2005

Barr files suit on Allegra-D challenging FDA policy

Also on Hatch-Waxman, from Reuters:

Barr Pharmaceuticals Inc said on February 4, 2005 it sued the U.S. Food and Drug Administration, seeking exclusive rights to sell a generic version of Aventis' Allegra-D allergy drug.

Barr said its lawsuit challenges the FDA's policy of awarding generic exclusivity on a patent-by-patent basis, rather than solely to the first company to file a patent challenge.

Barr filed suit in the U.S. District Court for the District of Columbia. Barr won tentative approval to market generic Allegra-D in July.

The active compound in Allegra is fexofenadine.


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