Alembic Pharma receives USFDA nod for Adapalene and Benzoyl Peroxide Topical Gel

Alembic Pharma receives USFDA nod for Adapalene and Benzoyl Peroxide Topical Gel

by admin- Monday, August 8th, 2022 03:48:23 PM

Alembic Pharmaceuticals introduced that its wholly owned subsidiary, Aleor Dermaceuticals Ltd (Aleor) has obtained final approval from the USA Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Adapalene and Benzoyl Peroxide Topical Gel, 0.Three%/2.5%. The authorised ANDA is .
Therapeutically equivalent to the reference listed drug product (RLD) Epiduo Forte Topical Gel, 0.3%/2.Five%, of Galderma Laboratories, L.P; (Galderma). Adapalene and Benzoyl Peroxide Topical Gel, 0.Three%/2.Five% is indicated for the topical treatment of pimples vulgaris in adults and pediatric sufferers 12 years of age and older.

Adapalene and Benzoyl Peroxide Topical Gel, zero.Three%/2.Five% has an anticipated marketplace length of US$211 million for one year ending Mar 2022 in keeping with IQVIA.

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