FDA approves Aleor’s adapalene gel for acne vulgaris

June 26, 2020

The U.S. Food and Drug Administration has approved the Abbreviated New Drug Application for topical retinoid adapalene gel USP, 0.3% from Alembic Pharmaceuticals and its joint venture Aleor Dermaceuticals for treatment of acne vulgaris.

Alembic Pharmaceuticals and its joint venture Aleor Dermaceuticals announced the U.S. Food and Drug Administration (FDA) has approved the Abbreviated New Drug Application (ANDA) for adapalene gel USP, 0.3%.

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The ANDA for the topical retinoid is now approved to be therapeutically equivalent to the reference listed drug product (RLD), Differin Gel 0.3% (Galderma).

Adapalene gel USP, 0.3% is intended to treat acne vulgaris in patients ages 12 years and older.

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The projected market size for the drug is $34 million over 12 months, according to a press release.

This ANDA joins Alembic’s list of over 100 ANDA approvals (110 final approvals and 13 tentative approvals) from the FDA.