Alembic Pharma has received approval for its abbreviated new drug application (ANDA) Acyclovir ointment USP, 5 %, from the USFDA.
The approved ointment is therapeutically equivalent to the reference listed drug product (RLD) Zovirax ointment 5 per cent of Valeant Pharmaceuticals North America LLC.
The drug is used for management of initial genital herpes and in limited non-life-threatening mucocutaneous herpes simplex virus infections in immunocompromised patients, the company said.