Alembic Pharmaceuticals has received final approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Oseltamivir Phosphate for Oral Suspension, 6 mg/mL.
The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Tamiflu Oral Suspension, 6 mg/mL, of Hoffmann-La Roche Inc.
Oseltamivir Phosphate is an influenza neuraminidase inhibitor indicated for the treatment of acute, uncomplicated influenza A and B in patients aged two weeks and older who have been symptomatic for no more than 48 hours. It is also indicated for the prophylaxis of influenza A and B in patients aged one year and older. The company advised referring to the product label for detailed indications.
According to IQVIA, Oseltamivir Phosphate for Oral Suspension, 6 mg/mL, has an estimated market size of US$27 million for the 12 months ended March 2026.
With this approval, Alembic now has a cumulative total of 243 ANDA approvals from the USFDA, comprising 223 final approvals and 20 tentative approvals.