FDA approves Mylan's ANDA for generic Antivert

Mylan Inc. (Nasdaq: MYL) today announced that its subsidiary Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Meclizine Hydrochloride Tablets USP, 12.5 mg, 25 mg and 50 mg. This product is the generic version of Pfizer's Antivert^®, which is indicated for the management of nausea and vomiting, and dizziness associated with motion sickness.

Antivert® Tablets, 12.5 mg, 25 mg and 50 mg, had U.S. sales of approximately $53.5 million for the 12 months ending June 30, 2012, according to IMS Health. Mylan is shipping this product immediately.

Currently, Mylan has 169 ANDAs pending FDA approval representing $79.4 billion in annual sales, according to IMS Health. Thirty-four of these pending ANDAs are potential first-to-file opportunities, representing $22.4 billion in annual brand sales, for the 12 months ending June 30, 2012, according to IMS Health.