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. Acyclovir ointment USP, 5%, has an estimated market size of $145 million for twelve months ending December 2016, according to IMS.
Alembic Pharmaceuticals, a vertically integrated research and development pharmaceutical company, has been at the forefront of Healthcare since 1907. The company now has a total of 71 ANDA approvals (63 final approvals and 8 tentative approvals) from USFDA.
