Strides Pharma arm gets tentative USFDA nod for skin ointment
New Delhi: Strides Pharma Science on Friday said its arm has received tentative nod from US health regulator for triamcinolone acetonide ointment used in 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 at Bangalore 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, the final approval for Strides Pharma will be effective 30 May 2020 when the company will launch the product.
According to IQVIA MAT data, the US market for triamcinolone acetonide ointment USP, 0.05 per cent is approximately USD 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.