Impax gets FDA OK for generic Allegra-D

HAYWARD, Calif. — The Food and Drug Administration has approved a generic treatment made by Impax for seasonal allergies, Impax said Tuesday.

 

The drug maker announced the approval of its generic version of Sanofi-Aventis’ Allegra-D (fexofenadine hydrochloride and pseudoephedrine hydrochloride) tablets in the 60-mg/120-mg strength.

 

 

Because Impax was the first company to file for approval of a generic version of the drug, the FDA has awarded it 180 days of market exclusivity in which to compete directly with the branded version.

 

 

Allegra-D had sales of $214 million during the 12-month period ended in September, according to Wolters Kluwer Health.

 

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