Last Updated on October 17, 2024 by The Health Master
Aleor Dermaceuticals receives USFDA nod for scalp psoriasis product
Alembic Pharmaceuticals has announced that its joint venture, Aleor Dermaceuticals has received approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Clobetasol Propionate Shampoo, 0.05%.
Shampoo
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Clobex Shampoo, 0.05%, of Galderma Laboratories. 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.
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Clobetasol Propionate Shampoo, 0.05%, has an estimated market size of $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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