Alembic Pharma JV gets USFDA nod for plaque psoriasis treatment drug

Alembic Pharmaceuticals on Friday said its joint venture (JV) firm Aleor Dermaceuticals has received approval from the US health regulator for Clobetasol Propionate spray, used to treat plaque psoriasis. The approved product is therapeutically equivalent to the reference listed drug product (RLD), Clobex spray, 0.05 per cent of Galderma Laboratories L P.

"Aleor Dermaceuticals Ltd has received approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) Clobetasol Propionate Spray, 0.05 per cent," Alembic Pharmaceuticals said in a regulatory filing.

Clobetasol Propionate Spray, 0.05 per cent is indicated for the treatment of moderate to severe plaque psoriasis.


Quoting IQVIA data, Alembic Pharma said Clobetasol Propionate Spray, 0.05 per cent, has an estimated market size of USD 22 million for twelve months ending December 2018.

Alembic has a cumulative total of 103 ANDA approvals (91 final approvals and 12 tentative approvals) from USFDA.

Shares of Alembic Pharma were trading 1.80 per cent higher at Rs 535 apiece on the BSE.