Alembic Pharma arm gets USFDA nod for fever blisters cream Docosanol
Docosanol Cream, 10% (OTC) is used for cold sore/fever blisters on the face or lips.
Vadodara: Alembic Pharmaceuticals Limited today announced that the company's wholly owned subsidiary, Aleor Dermaceuticals Limited 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. Cold sore is a group of tiny, painful blisters caused by a virus called herpes simplex.
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.
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Alembic Pharmaceuticals Limited is a vertically integrated research and development pharmaceutical company headquartered in Gujarat. Alembic is a publicly listed company that manufactures and markets generic pharmaceutical products all over the world. Alembic's state of the art research and manufacturing facilities are approved by regulatory authorities of many developed countries including the USFDA.
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