Strides receives USFDA tentative approval for Triamcinolone Acetonide ointment
Product approval from flagship facility in Bengaluru; to be marketed by Strides Pharma Inc. effective May 30,2020
Strides Pharma Science Limited recently announced that its step-down wholly owned subsidiary, Strides Pharma Global Pte. Limited, Singapore, has received tentative approval for Triamcinolone Acetonide ointment USP, 0.05 per cent from the United States Food and Drug Administration (USFDA).
While it was amongst the few Competitive Generic Therapy (CGT) designated products for Strides, another generic company received approval prior to our approval. Consequently, the final approval for Strides will be effective 30th 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 US$ 20 million. 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.
The company has 102 cumulative ANDA filings with USFDA of which 69 have been approved and 33 are pending for approval.
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