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Strides Shasun gets USFDA nod for two products

Strides Shasun gets USFDA nod for two products

New Delhi: Pharmaceutical company Strides Shasun said its wholly-owned subsidiary has received approval from the US health regulator for Piroxicam capsules and anti-fungal cream Nystatin and Triamcinolone Acetonide Ointment.

In a BSE filing the company said, Strides Pharma Global Pte. Limited has received approval for Piroxicam capsules 10mg and 20mg from the United States Food and Drug Administration (USFDA).

Piroxicam is indicated for the symptomatic relief of rheumatoid arthritis, osteoarthritis or ankylosing spondylitis.

Citing IMS sales data, the company said the US market for Piroxicam is approximately USD 11 million and the US market for Nystatin and Triamcinolone Acetonide Ointment USP, 0.1 percent is approximately USD 18 million.

Both the products received approval within ten months under the USFDA’s new product clearance regime of GDUFA, the company said.

Source: PTI
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