Alembic Pharmaceuticals gets ANDA approval for Acyclovir ointment USP, 5%

From USFDA

Alembic Pharmaceuticals has received approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Acyclovir ointment USP, 5%. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Zovirax ointment 5%, of Valeant Pharmaceuticals North America LLC. Acyclovir ointment USP, 5% is indicated in the management of initial genital herpes and in limited non-life-threatening mucocutaneous Herpes simplex virus infections in immunocompromised patients.

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