Strides Pharma gets USFDA nod for generic version of triamcinolone acetonide to treat skin conditions
The approval is granted to the company's step-down wholly-owned subsidiary, Strides Pharma Global, Singapore, by USFDA for triamcinolone acetonide ointment USP, 0.05 percent.
New Delhi: Strides Pharma Science on Tuesday said it has received US health regulator's approval for its generic version of vers ointment used for the treatment of various skin conditions.
The approval is granted to the company's step-down wholly-owned subsidiary, Strides Pharma Global, Singapore, by the United States Food and Drug Administration (USFDA) for triamcinolone acetonide ointment USP, 0.05 percent, Strides Pharma Science said in a regulatory filing.
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"The product is part of the niche and small volume product portfolio with limited competition in the US market," it added.
Citing IQVIA data, the company said the US market for triamcinolone acetonide ointment USP, 0.05 percent, is approximately USD 15 million.
"The product will be manufactured at the company's flagship facility at Bengaluru and will be marketed by Strides Pharma in the US market," it added.
The company has 124 cumulative abbreviated new drug application filings with USFDA of which 86 have been approved and 38 are pending clearance.
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