Alembic Pharmaceuticals, a Rs.3,100 crore pharma major from Vadodara, has received US FDA approval for acyclovir ointment USP, 5 per cent. The approved ANDA is therapeutically equivalent to the reference listed drug product 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% have an estimated market size of US$ 145 million for twelve months ending December 2016 according to IQVIA.
Alembic now has a total of 71 ANDA approvals (63 final approvals and 8 tentative approvals) from US FDA.