Alembic Pharmaceuticals announced that its joint venture Aleor
Dermaceuticals (Aleor) has received approval from - the US Food & Drug
Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Clobetasol
Propionate Spray, 0.05%. The approved ANDA is therapeutically equivalent to the reference
listed drug product (RLD), Clobex Spray, 0.05% of Galderma Laboratories L.P. (Galderma).
Clobetasol Propionate Spray, 0.05% is indicated for the treatment of moderate to severe
plaque psoriasis affecting up to 20% body surface area (BSA) in patients 18 years of age or
older.
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