Alembic Pharmaceuticals said Wednesday that its wholly-owned subsidiary, Aleor Dermaceuticals, has received final approval from US health regulators for its generic Docosanol cream to treat cold sores/fever blisters on the face or lips.

The company said in a regulatory filing that the final approval from the US Food and Drug Administration (USFDA) was an Abbreviated New Drug Application (ANDA) for 10 per cent docosanol cream (over-the-counter).

It added that the approved ANDA is therapeutically equivalent to GSK Consumer Healthcare’s reference marketed drug Abreva Cream, 10 per cent (OTC). Citing data from IQVIA, Alembic said the market for 10 per cent docosanol cream (OTC) was estimated at $60 million in the 12 months to December 2021. Alembic had received 166 ANDA approvals (142 final and 24 tentatives) from the USFDA.