Aleor Dermaceuticals receives USFDA final approval for Adapalene and Benzoyl Peroxide Topical Gel for acne

Adapalene and Benzoyl Peroxide Topical Gel, 0.3%/2.5% is indicated for the topical treatment of acne vulgaris in adults and pediatric patients 12 years of age and older.

Aleor Dermaceuticals receives USFDA final approval for Adapalene and Benzoyl Peroxide Topical Gel for acne
Acne is a skin condition that occurs when hair follicles plug with oil and dead skin cells (File)

Alembic Pharmaceuticals Limited on Monday announced that its 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 Adapalene and Benzoyl Peroxide Topical Gel, 0.3%/2.5%.

According to the company’s press statement, the approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Epiduo Forte Topical Gel, 0.3%/2.5%, of Galderma Laboratories, L.P. (Galderma). Adapalene and Benzoyl Peroxide Topical Gel, 0.3%/2.5% is indicated for the topical treatment of acne vulgaris in adults and pediatric patients 12 years of age and older.
 
According to IQVIA, Adapalene and Benzoyl Peroxide Topical Gel, 0.3%/2.5% has an estimated market size of US$211 million for twelve months ending March 2022. The company also claimed that Alembic has received a cumulative total of 170 ANDA approvals (146 final approvals and 24 tentative approvals) from USFDA.

ALSO READ | Glenmark Pharmaceuticals launches India’s first Topical Minocycline 4% Gel for moderate to severe acne

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