Strides Pharma arm gets tentative USFDA nod for skin ointment
The product will be manufactured at the company's oral dosage facility at Bengaluru and will be marketed by Strides Pharma Inc in the US market
Strides Pharma has said its arm has received tentative nod from the 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 and Drug Administration (USFDA)”.
The product will be manufactured at the company’s oral dosage facility at 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, the final approval for Strides Pharma will be effective 30th May, 2020 when the company will launch the product.