Alembic Pharma's JV gets USFDA’s final approval for Clobetasol Propionate Cream

29 Jan 2020 Evaluate

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.

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