Aleor Dermaceuticals receives USFDA Final Approval for Docosanol Cream, 10% (OTC)

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Alembic Pharmaceuticals Limited (Alembic) today 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% (OTC).

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Abreva Cream, 10% (OTC), of GlaxoSmithKline Consumer Healthcare. Docosanol Cream, 10% (OTC) is used for cold sore/fever blisters on the face or lips.

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

Alembic has received a cumulative total of 166 ANDA approvals (142 final approvals and 24 tentative approvals) from USFDA.