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Aleor Dermaceuticals receives USFDA approval for Clobetasol Propionate Shampoo

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Alembic Pharmaceuticals announced that its JV, Aleor Dermaceuticals has received US Food and Drug Administration (USFDA) Approval for Clobetasol Propionate Shampoo, 0.05%.

The approved AN DA is therapeutically equivalent to the reference listed drug product (RLD), Clobex Shampoo, 0.05%, of Galderma Laboratories, L.

P. (Galderma). Clobetasol Propionate Shampoo, 0.05% is indicated for the treatment of moderate to severe forms of scalp psoriasis in subjects 18 years of age and older.

Clobetasol Propionate Shampoo, 0.05%, has an estimated market size of US$ 28 million for twelve months ending December 2019 according to IQVIA.

Alembic has a cumulative total of 122 ANDA approvals (109 final approvals and 13 tentative approvals) from USFDA.

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(This story has not been edited by Business Standard staff and is auto-generated from a syndicated feed.)

First Published: Tue, May 19 2020. 13:43 IST
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