FDAnews Drug Daily Bulletin

MYLAN, DR. REDDY'S GET APPROVAL FOR GENERIC ALLEGRA

April 24, 2006
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Mylan Pharmaceuticals and Dr. Reddy's Laboratories have received approval to market generic versions of Aventis Pharmaceuticals' allergy drug Allegra.

Indian drug firm Dr. Reddy's plans to launch its product immediately, while Mylan received tentative approval for its product. Because Dr. Reddy's filed its abbreviated new drug application much earlier than its competitors, it probably will be at least four months before Mylan, Impax, Sandoz or Ranbaxy Laboratories launch versions of the drug, Merrill Lynch analyst Visalakshi Chandramouli said in an recent note.

Teva is the only generic drugmaker marketing generic Allegra (fexofenadine HCl) apart from Prasco's authorized generic. Barr and Teva jointly launched generic Allegra at risk in September. Aventis -- a subsidiary of sanofi-aventis -- and drug development partner Albany Molecular Research tried to get an injunction to stop Barr and Teva from selling their product. But the U.S. District Court for the District of New Jersey refused to block the drugmakers from selling their 30-, 60-and 180-mg tablets of generic Allegra.