Alembic Pharmaceuticals receives USFDA approval for Oseltamivir Phosphate for Oral Suspension, 6 mg/mL
India, June 26 -- Alembic Pharmaceuticals (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.Oseltamivir Phosphate for Oral Suspension, 6 mg/mL...
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