Alembic Pharma JV Aleor gets USFDA nod for Clobetasol Propionate ointment

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.

New Delhi: Drug firm Alembic Pharmaceuticals Tuesday said it's 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. This medication is used to treat a variety of skin conditions including eczema, psoriasis, dermatitis, allergies, rash. Clobetasol reduces the swelling, itching, and redness that can occur in these types of conditions. This medication is a very strong (super-high-potency) corticosteroid.

Also Read: Alembic Pharma gets USFDA nod for Acetazolamide extended-release capsules

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.

Alembic Pharmaceuticals Ltd. is headquartered in Vadodara city of Gujarat. The company is involved in manufacture of pharmaceutical products, pharmaceutical substances and intermediates. It is also termed to be a market leader in macrolides segment of anti-infective drugs in India.

Also Read: Zydus Cadila gets USFDA nod for skin ointment, stomach ailment drug