Alembic Pharma today said it has received approval from the US health regulator for its Acyclovir ointment USP, used for the treatment of genital herpes. The company has received approval from the USFDA for its abbreviated new drug application (ANDA) Acyclovir ointment USP, 5 per cent, Alembic Pharmaceuticals said in a BSE filing.
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.
According to IMS data, for the twelve months ending December 2016, the ointment has an estimated market size of $145 million. Shares of Alembic Pharmaceuticals were trading 0.77 per cent up at Rs 545 on BSE.