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Strides receive USFDA approval for Oseltamivir Phosphate for Oral Suspension
Strides Pharma Science Limited today announced its step-down wholly-owned subsidiary, Strides Pharma Global Pte.
Strides Pharma Science Limited today announced its step-down wholly-owned subsidiary, Strides Pharma Global Pte. Limited, Singapore, has received approval for Oseltamivir Phosphate for Oral Suspension,6 mg/mL from the United States Food & Drug Administration (USFDA). The products will be marketed in the US market by Strides Pharma Inc.
The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Tamiflu for Oral Suspension, 6 mg/mL, of Hoffmann-La Roche, Inc.
According to IQVIA MAT November 2020 data, the US market for Oseltamivir Phosphate for Oral Suspension, 6 mg/mL was approximately US$ 132 million. The product will be manufactured at the company's facility in Bengaluru and will be marketed by Strides Pharma Inc. in the US market.
The company has 271 cumulative ANDA filings with USFDA of which 243 ANDAs have been approved and 28 are pending approval.
Oseltamivir Phosphate for Oral Suspension, 6 mg/mL is indicated for i) treatment of acute, uncomplicated influenza A and B in patients 2 weeks of age and older who have been symptomatic for no more than 48 hours and ii) prophylaxis of influenza A and B in patients 1 year and older.