Aurobindo Receives FDA Approval for Oseltamivir Phosphate for Oral Suspension, 6 mg/mL
Published: May 10, 2024
East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application Oseltamivir Phosphate for Oral Suspension, 6 mg/mL. Aurobindo Pharma’s Oseltamivir Phosphate for Oral Suspension, are an AB-rated generic equivalent to the reference listed drug (RLD), Tamiflu® for Oral Suspension manufactured by Hoffmann-La Roche, Inc.
Oseltamivir Phosphate for Oral Suspension, 6 mg/mL are 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
- Prophylaxis of influenza A and B in patients 1 year and older.