Alembic Pharma arm gets USFDA nod for generic topical gel for acne vulgaris


PTI | New Delhi | Updated: 08-08-2022 12:43 IST | Created: 08-08-2022 12:41 IST
Alembic Pharma arm gets USFDA nod for generic topical gel for acne vulgaris
Alembic Pharma
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  • India

Alembic Pharmaceuticals on Monday said its wholly-owned arm Aleor Dermaceuticals has received final approval from the US health regulator for its generic version of a topical gel used to treat acne vulgaris.

The approval by the US Food and Drug Administration (USFDA) is for the abbreviated new drug application (ANDA) for adapalene and benzoyl peroxide topical gel of strength 0.3 per cent/2.5 per cent, Alembic said in a statement.

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Epiduo Forte topical gel of Galderma Laboratories, L.P. (Galderma), it added.

The gel is indicated for the topical treatment of acne vulgaris in adults and pediatric patients 12 years of age and older, the company said.

Citing IQVIA data, Alembic said adapalene and benzoyl peroxide topical gel, 0.3 per cent/2.5 per cent had an estimated market size of USD 211 million for the 12 months ended March 2022.

The company has so far received 170 ANDA approvals (146 final approvals and 24 tentative approvals) from the USFDA, the statement said.

(This story has not been edited by Devdiscourse staff and is auto-generated from a syndicated feed.)

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