Alembic Pharma's JV Aleor gets USFDA nod for generic skin conditions ointment

Drug firm Alembic Pharmaceuticals Tuesday said its joint venture firm Aleor Dermaceuticals has received approval from the US health regulator for its generic Clobetasol Propionate ointment, used for relief of symptoms of corticosteroid-responsive dermatoses.

The company's JV, Aleor Dermaceuticals Ltd, has received approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application for Clobetasol Propionate ointment USP, 0.05 per cent, Alembic Pharmaceuticals said in a filing to BSE.

The product is a generic version of Glaxo Wellcome Inc's Temovate ointment in the same strength, it added.

According to IQVIA, Clobetasol Propionate ointment USP, 0.05 per cent, has an estimated market size of USD 63 million for twelve months ending December 2018, Alembic Pharmaceuticals said.

The ointment is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses, it added.

Alembic Pharmaceuticals has a cumulative total of 88 ANDA approvals (75 final approvals and 13 tentative approvals) from USFDA, the company said.

Aleor is a 60:40 joint venture between Alembic and Orbicular Pharmaceutical Technologies Pvt Ltd.

Shares of Alembic Pharmaceuticals closed at Rs 549.80 per scrip on BSE, down 0.01 per cent from its previous close.