Aleor Dermaceuticals receives final USFDA approval for new cold sore drug

India Pharma Outlook Team | Wednesday, 04 May 2022

Alembic Pharmaceuticals Limited (Alembic) announced that its wholly-owned subsidiary, Aleor Dermaceuticals Limited (Aleor) has received final approval from the

US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Docosanol Cream, 10 per cent (OTC).

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Abreva Cream, 10 per cent (OTC) by GlaxoSmithKline Consumer Healthcare. Docosanol Cream, 10 per cent (OTC), is used for cold sores or fever blisters on the face or lips. Alembic has received a cumulative total of 166 ANDA approvals (142 final approvals and 24 tentative approvals) from the USFDA.