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.