Strides Pharma Science Ltd on Monday said its Singapore-based arm has received approval from the US health regulator for its generic version of oseltamivir phosphate for oral suspension, used for treating illness due to influenza.
The approval granted by the US Food & Drug Administration (USFDA) to Strides Pharma Global Pte. Ltd, Singapore, is for oseltamivir phosphate for oral suspension of strength 6 mg/ml, the company said in a statement.
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, it added.
The product will be manufactured at the company's facility in Bengaluru and will be marketed by Strides Pharma Inc in the US market.
Citing IQVIA MAT November 2020 data, the company said the US market for oseltamivir phosphate for oral suspension, 6 mg/mL, was about USD 132 million.
Strides has 271 cumulative abbreviated new drug application (ANDAs) filings with USFDA, of which 243 ANDAs have been approved and 28 are pending approvals.