Alembic’s subsidiary, Aleor Dermaceuticals Limited receives USFDA Final Approval for Clobetasol Propionate Foam

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Alembic Pharmaceuticals Limited stated on Monday that Aleor Dermaceuticals Limited, a wholly-owned subsidiary of Alembic Pharmaceuticals Limited, has achieved final FDA approval for its Abbreviated New Drug Application (ANDA) for Clobetasol Propionate Foam, 0.05 percent.

The authorized ANDA is therapeutically equal to Mylan Pharmaceuticals Inc.’s reference listed drug product (RLD) Olux Foam, 0.05 percent.

Propionate of Clobetasol Foam is a corticosteroid used to treat moderate to severe plaque psoriasis of the scalp, as well as mild to moderate plaque psoriasis of non-scalp portions of the body, excluding the face and intertriginous areas, in people aged 12 and up.

According to IQVIA, Clobetasol Propionate Foam, 0.05 percent has a market size of US$10 million for the twelve months ending December 2021. Alembic has obtained 165 ANDA approvals from the USFDA (141 final approvals and 24 tentative clearances).


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