Mylan Inc. 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.
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