Alembic Pharma gets USFDA nod for generic Adapalene gel for acne treatment

The product was indicated for the topical treatment of acne vulgaris in patients 12 years of age and older, Alembic Pharma said

Alembic Pharmaceuticals on Friday said its joint venture had received nod from the US health regulator for generic Adapalene gel used for the treatment of acne.

The company's JV Aleor Dermaceuticals has received approval from the United States Food & Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Adapalene gel USP, 0.3 per cent, Alembic Pharma said in a filing to the BSE.

The approved product is a generic version of Galderma Laboratories LP's Differin gel in the same strength, it added.

According to IQVIA, Adapalene gel USP, 0.3 per cent, has an estimated market size of $34 million for twelve months ending March 2020, Alembic Pharma said.

The product is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older, it added.

The company has a cumulative total of 123 ANDA approvals (110 final approvals and 13 tentative approvals) from USFDA, Alembic Pharma said.

Shares of Alembic Pharmaceuticals were trading at Rs 934.20 per scrip on the BSE, up 2.85 per cent over previous close.