New Delhi: Glenmark Pharmaceuticals said it has received a final nod from US health regulator for its Clobetasol Propionate spray used for the treatment of moderate to severe plaque psoriasis in adults.
Glenmark Pharmaceuticals Inc, USA has received final approval by the United States Food and Drug Administration (USFDA) for Clobetasol Propionate spray 0.05 percent, the company said in a statement.
The product is a generic version of Galderma Laboratories L P’s Clobex spray in the same strength, it added.
This product will be manufactured at the Glenmark’s Baddi plant in Himachal Pradesh.
“As per IQVIA sales data for the 12 month period ending January 2018, the Clobex spray, 0.05 percent market that includes brand and all available therapeutic equivalents achieved annual sales of approximately USD 30.5 million,” it said.
The company’s portfolio consists of 131 products authorized for distribution in the US market and 63 ANDA’s pending approval with the USFDA, Glenmark said.