New Delhi: Glenmark Pharmaceuticals on Wednesday said it has received final approval from the US health regulator for generic Triamcinolone Acetonide ointment used for treating skin inflammation.
Glenmark Pharmaceuticals Inc USA has been granted final approval by the United States Food and Drug Administration (USFDA) for Triamcinolone Acetonide ointment USP, 0.1 per cent, the company said in a statement.
The product is a generic version of Mylan Pharmaceuticals Inc’s Kenalog ointment in the same strength, it added.
As per IMS Health sales data for the 12-month period ending June 2017, the Kenalog ointment 0.1 per cent and all available therapeutic equivalents achieved annual sales of around USD 26.3 million, Glenmark Pharmaceuticals said.
The company’s current portfolio consists of 122 products authorized for distribution in the US market and 64 Abbreviated New Drug Applications (ANDA’s) pending approval with the USFDA, it added.