Mylan Inc. announced that its subsidiary Mylan Pharmaceuticals Inc. received final approval from the US 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 US 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.