Alembic Pharmaceuticals’ joint venture (JV) Aleor Dermaceuticals (Aleor) has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Clobetasol Propionate Cream USP, 0.05%. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Temovate Cream, 0.05%, of Fougera Pharmaceuticals Inc. (Fougera). Clobetasol Propionate Cream is super-high potency corticosteroid formulations indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
Clobetasol Propionate Cream USP, 0.05% has an estimated market size of $57 million for twelve months ending September 2019 according to IQVIA. Alembic has a cumulative total of 118 ANDA approvals (106 final approvals and 12 tentative approvals) from USFDA.
Alembic Pharmaceuticals, a vertically integrated research and development pharmaceutical company, has been at the forefront of Healthcare since 1907.
