Aleor Dermaceuticals receives US FDA final approval for Docosanol cream

Alembic Pharma today announced that its wholly owned subsidiary, Aleor Dermaceuticals has received final approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Docosanol cream, 10% (OTC).

The approved ANDA is therapeutically equivalent to the Reference Listed Drug (RLD) product Abreva Cream, 10% (OTC), of GlaxoSmithKline Consumer Healthcare. Docosanol Cream, 10% (OTC) is used for cold sore/fever blisters on the face or lips, Alembic Pharma said in a statement.

Docosanol Cream, 10% (OTC) has an estimated market size of $60 million for twelve months ending December 2021, according to IQVIA, the statement added.