Alembic gets USFDA nod for Oseltamivir Phosphate for Oral Suspension
Oseltamivir Phosphate is an influenza neuraminidase inhibitor (NAI) indicated for 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 prophylaxis of influenza A and B in patients 1 year and older.
Alembic Pharmaceuticals 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. 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.
Oseltamivir Phosphate for Oral Suspension, 6 mg/mL, have an estimated market size of $ 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.