Aleor Dermaceuticals gets US FDA nod for Adapalene Gel USP
It is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older
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.