FDA approves Mylan's ANDA for generic version of Zovirax Ointment

Apr 4 2013

Mylan Inc. (Nasdaq: MYL) 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.