Strides Pharma Science gets FDA approval for Tamiflu generic
Strides Pharma Science Limited said that Strides Pharma Global Pte. Limited, Singapore, its step-down fully-owned subsidiary, has secured approval for Oseltamivir Phosphate for Oral Suspension,6 mg/mL from the US Food & Drug Administration (FDA).
The drug is bioequivalent and therapeutically equivalent to Tamiflu for Oral Suspension, 6 mg/mL, of Hoffmann-La Roche (Roche).
As per IQVIA MAT November 2020 data, the US market for Oseltamivir Phosphate for Oral Suspension, 6 mg/mL was around $132 million.
Strides Pharma Science said that the drug will be manufactured at its Bengaluru facility and will be marketed by Strides Pharma in the US market.
The Indian pharma company has 271 cumulative ANDA filings with the FDA, of which 243 ANDAs have been approved, while 28 are pending approval.