Alembic JV Aleor Derma gets USFDA nod for therapeutic equivalent of Clobex Spray

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. The product is therapeutically equivalent to the reference listed drug product (RLD), Clobex Spray, 0.05% of Galderma Laboratories L.P. (Galderma), Alembic Pharma said.

New Delhi: Alembic Pharmaceuticals Limited (Alembic) today announced that its joint venture Aleor Dermaceuticals Limited (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).

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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.

Clobetasol Propionate Spray, 0.05%, has an estimated market size of US$ 22 million for twelve months ending December 2018 according to IQVIA.

Alembic has a cumulative total of 103 ANDA approvals (91 final approvals and 12 tentative approvals) from USFDA.

Alembic Pharmaceuticals Ltd. is headquartered in Vadodara city of Gujarat. The company is involved in the manufacture of pharmaceutical products, pharmaceutical substances and intermediates. It is also termed to be a market leader in macrolides segment of anti-infective drugs in India.

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