Mumbai, April 16, 2018: Pharma Major, Alembic Pharma said that it has received USFDA approval for its Abbreviated New Drug Application (ANDA) Acyclovir ointment USP, 5 per cent.
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Zovirax ointment 5 per cent, of Valeant Pharmaceuticals North America LLC. Acyclovir ointment USP 5 per cent, is indicated in the management of initial genital herpes and in limited non-life-threatening mucocutaneous Herpes simplex virus infections in immunocompromised patients.
Acyclovir, 5 per cent, have an estimated market size USD 145 million for twelve months ending December 2016 according to IMS. Alembic now has a total of 71 ANDA approvals (63 final approvals and 8 tentative approvals) from USFDA.
United News of India