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FDA approves Mylan’s ANDA for Acyclovir Ointment

The US FDA has granted final approval for Mylan Pharmaceuticals' abbreviated new drug application (ANDA) for Acyclovir Ointment USP, 5%.

Acyclovir Ointment is the generic equivalent to Zovirax Ointment from Valeant International.

Mylan has begun immediate product shipment.

Zovirax Ointment is indicated for the management of initial genital herpes and in limited non-life-threatening mucocutaneous herpes simplex virus infections in immunocompromised patients.

Based on IMS Health data, US sales of Acyclovir Ointment USP, 5% were approximately $230m for the 12 months ending 31 December 2012.