Strides Pharma subsidiary gets USFDA nod for Oseltamivir Phosphate for Oral Suspension
Bengaluru: Strides Pharma Science Limited has recently announced that 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 product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Tamiflu for Oral Suspension, 6 mg/mL, of Hoffmann-La Roche, Inc.
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.
The product will be manufactured at the company's facility at Bengaluru and will be marketed by Strides Pharma Inc. in the US market.
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