Mylan Launches First Generic Version of Zovirax® Ointment

Mylan Inc.

today announced that its subsidiary Mylan Pharmaceuticals has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Acyclovir Ointment USP, 5%. This product is the first generic version of Valeant International's Zovirax^® Ointment, which is indicated in the management of initial genital herpes and in limited non-life-threatening mucocutaneous herpes simplex virus infections in immunocompromised patients. Acyclovir Ointment USP, 5% had U.S. sales of approximately $230 million for the 12 months ending Dec. 31, 2012, according to IMS Health. Mylan is shipping this product immediately. Currently, Mylan has 178 ANDAs pending FDA approval representing $78.4 billion in annual sales, according to IMS Health.  Thirty-five of these pending ANDAs are potential first-to-file opportunities, representing $20.3 billion in annual brand sales, for the 12 months ending June 30, 2012, according to IMS Health.