The US Food and Drug Administration (FDA) has granted final approval for Mylan Pharmaceuticals' Abbreviated New Drug Application (ANDA) for Acyclovir Ointment USP, five per cent. 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, five per cent had US 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.
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