Mylan Receives Approval for Hydroxyzine Hydrochloride Tablets
PITTSBURGH, June 17 /PRNewswire-FirstCall/ -- Mylan Inc. (Nasdaq: MYL) today announced that its subsidiary Mylan Pharmaceuticals Inc. received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Hydroxyzine Hydrochloride Tablets 10 mg, 25 mg and 50 mg. The product was determined to be bioequivalent and, therefore, therapeutically equivalent to Pliva's Hydroxyzine Hydrochloride Tablets, a treatment for nervousness and tension.
Hydroxyzine Hydrochloride Tablets had U.S. sales of approximately $55 million for the 12 months ending March 31, 2010, according to IMS Health.
Currently, Mylan has 138 ANDAs pending FDA approval representing $95.2 billion in annual brand sales, according to IMS Health. Forty of these pending ANDAs are potential first-to-file opportunities, representing $21 billion in annual brand sales, for the 12 months ending Dec. 31, 2009 according to IMS Health.
Mylan Inc. ranks among the leading generic and specialty pharmaceutical companies in the world and provides products to customers in more than 140 countries and territories. The company maintains one of the industry's broadest and highest quality product portfolios supported by a robust product pipeline; operates one of the world's largest active pharmaceutical ingredient manufacturers; and runs a specialty business focused on respiratory, allergy and psychiatric therapies. For more information, please visit