Alembic Pharmaceuticals Limited announces USFDA Final Approval for Oseltamivir Phosphate for Oral Suspension

Alembic Pharmaceuticals Limited (Alembic) today announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Oseltamivir Phosphate for Oral Suspension, 6 mg/mL. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Tamiflu Oral Suspension, 6 mg/mL, of Hoffmann-La Roche, Inc. Oseltamivir Phosphate is an influenza neuraminidase inhibitor (NAI) 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. Refer label for a detailed indication.

Oseltamivir Phosphate for Oral Suspension, 6 mg/mL, have an estimated market size of US$ 27 million for twelve months ending March 2026 according to IQVIA.

Alembic has a cumulative total of 243 ANDA approvals (223 final approvals and 20 tentative approvals) from USFDA.