Alembic Pharmaceuticals’ joint venture (JV) Aleor Dermaceuticals (Aleor) has received approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Clobetasol Propionate Topical Solution USP, 0.05%. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Temovate Topical Solution, 0.05%, of Fougera Pharmaceuticals Inc. (Fougera). Clobetasol Propionate Topical Solution USP, 0.05% is indicated for short-term topical treatment of inflammatory and pruritic manifestations of moderate to severe corticosteroid-responsive dermatoses of the scalp.
Clobetasol Propionate Topical Solution USP, 0.05%, has an estimated market size of $33 million for twelve months ending December 2018 according to IQVIA. Alembic has a cumulative total of 104 ANDA approvals (92 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.
