Glenmark gets USFDA nod for generic skin ointment

Tunia Cherian Updated - January 09, 2018 at 07:40 PM.

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Glenmark Pharmaceuticals today 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.

According to IMS Health sales data for the 12-month period ending June 2017, Kenalog ointment 0.1 per cent and all available therapeutic equivalents achieved annual sales of around $26.3 million, Glenmark Pharmaceuticals said.

The company’s current portfolio consists of 122 products authorised for distribution in the US market and 64 Abbreviated New Drug Applications (ANDA’s) pending approval with the USFDA, it added.

Shares of Glenmark Pharmaceuticals were today trading at Rs 596.60 per scrip in afternoon trade on the BSE, down 0.80 per cent from the previous close.

Published on August 23, 2017 09:29