Companies

Strides Pharma arm gets tentative USFDA nod for skin ointment

PTI New Delhi | Updated on January 24, 2020 Published on January 24, 2020

Strides Pharma Science Ltd logo   -  Website/strides

Strides Pharma Science on Friday said its arm has received a tentative nod from the US health regulator for triamcinolone acetonide ointment used in the treatment of various skin conditions.

In a regulatory filing, the company said “its step-down wholly-owned subsidiary, Strides Pharma Global Pte Ltd, Singapore, has received tentative approval for triamcinolone acetonide ointment USP, 0.05 per cent from the United States Food & Drug Administration (USFDA)”.

The product will be manufactured at the company’s oral dosage facility in Bengaluru and will be marketed by Strides Pharma Inc in the US market.

“While it was amongst the few competitive generic therapy designated products for Strides, another generic company received approval prior to our approval,” the filing said.

Consequently, final approval for Strides Pharma will be effective May 30, 2020, when the company launches the product.

According to IQVIA MAT data, the US market for triamcinolone acetonide ointment USP, 0.05 per cent is approximately $20 million.

The company has 102 cumulative abbreviated new drug application (ANDA) filings with USFDA, of which 69 ANDAs have been approved and 33 are pending approval.

The shares of Strides Pharma Science were trading at Rs 416.40 a piece on the BSE, up 1.01 per cent from the previous close.

Published on January 24, 2020
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