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 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.
