Glenmark Pharmaceuticals has received final approval from the US health regulator for the generic Calcipotriene cream used for the treatment of plaque psoriasis.
The company plans to commence shipping of the product immediately, it said in a statement.
“Glenmark Pharmaceuticals USA has been granted final approval by the United States Food & Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Calcipotriene Cream 0.005 per cent,” it said.
The product is the generic version of Leo Pharma A/S’s Dovonex cream 0.005 per cent.
Plaque psoriasis is a skin disease and appears as raised, red patches covered with a silvery white build-up of dead skin cells or scales mostly around scalp, knees and elbows.
According to IMS Health sales data for the 12 months to April 2015, the Dovonex market — including brand and all available therapeutic equivalents — achieved annual sales of approximately $91.9 million, Glenmark said.
“Glenmark’s current portfolio consists of 98 products authorised for distribution in the US market and 67 ANDAs pending approval with USFDA,” the company said.
The company, along with its subsidiary, has 14 manufacturing facilities across four countries and six R&D centres.
Glenmark Pharma shares were trading at Rs 867.35 in the afternoon trade on BSE, up 1.19 per cent.