Strides Shasun’s wholly-owned subsidiary has received approval from the US health regulator for Piroxicam capsules and anti-fungal cream Nystatin and Triamcinolone Acetonide ointment.
The company said in a BSE filing today that Strides Pharma Global Pte Ltd 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 $11 million and the US market for Nystatin and Triamcinolone Acetonide ointment USP, 0.1 per cent is approximately $18 million.
Both the products have received approval within ten months under the USFDA’s new product clearance regime of GDUFA, the company said. The company’s stock was trading 0.84 per cent lower at Rs 778.95 apiece on the BSE.
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