Alembic JV firm gets USFDA nod to market generic scalp psoriasis product

Alembic Pharmaceuticals on Tuesday said its joint venture firm has received approval from the US health regulator to market Clobetasol Propionate shampoo, used in treatment of scalp psoriasis. The company's joint venture, Aleor Dermaceuticals Ltd (Aleor), has received approval from the US Food & Drug Administration (USFDA) for its abbreviated new drug application (ANDA), Alembic Pharma said in a regulatory filing.

The approved ANDA is generic version of Galderma Laboratories' Clobex Shampoo, which is  indicated for the treatment of moderate to severe forms of scalp psoriasis in subjects 18 years of age and older. According to IQVIA, Clobetasol Propionate Shampoo, 0.05 per cent, has an estimated market size of USD 28 million for twelve months ending December 2019.