Aleor Dermaceuticals gets US FDA nod for Adapalene Gel USP

Alembic Pharmaceuticals has announced that its joint venture Aleor Dermaceuticals has received approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Adapalene Gel USP, 0.3%.

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Differin Gel, 0.3%, of Galderma Laboratories, L.P. (Galderma).

Adapalene Gel USP, 0.3% is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older.

Adapalene Gel USP, 0.3% has an estimated market size of $34 million for twelve months ending March 2020 according to IQVIA.

Alembic has a cumulative total of 123 ANDA approvals (110 final approvals and 13 tentative approvals) from USFDA.