Alembic Pharmaceuticals’ (Alembic) 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 Ointment USP, 0.05%. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Temovate Ointment USP, 0.05% of Glaxo Wellcome Inc. Clobetasol Propionate Ointment USP, 0.05% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
Clobetasol Propionate Ointment USP, 0.05%, has an estimated market size of US$ 63 million for twelve months ending December 2018 according to IQVIA. The company has a cumulative total of 88 ANDA approvals (75 final approvals and 13 tentative approvals) from USFDA.
Alembic Pharmaceuticals, a vertically integrated research and development pharmaceutical company, has been at the forefront of Healthcare since 1907.
