Alembic Pharmaceuticals Limited's wholly owned subsidiary, Aleor Dermaceuticals Limited has received final approval from the US Food & 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 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 US FDA.
Alembic Pharmaceuticals Limited, a vertically integrated research and development pharmaceutical company, has been at the forefront of healthcare since 1907.
