Strides Pharma’s Singapore arm gets US FDA nod for generic version of oseltamivir phosphate
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
Strides Pharma recently 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 and Drug Administration (FDA) to Strides Pharma Global, 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 $132 million.
Strides has 271 cumulative Abbreviated New Drug Application (ANDAs) filings with US FDA, of which 243 ANDAs have been approved and 28 are pending approvals.
- Advertisement -