Alembic Pharmaceuticals Limited has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for oseltamivir phosphate for oral suspension, 6 mg/mL.
The approval allows the company to market a generic version of Tamiflu oral suspension in the United States, expanding its respiratory medicine portfolio and strengthening its presence in the U.S. generics market.
FDA Approves Generic Version of Tamiflu Oral Suspension
The approved product is therapeutically equivalent to the reference listed drug (RLD), Tamiflu oral suspension, 6 mg/mL, developed by Hoffmann-La Roche, Inc.
With this approval, Alembic can offer a lower-cost generic alternative for patients and healthcare providers treating and preventing seasonal influenza.
What Is Oseltamivir Phosphate Used For?
Oseltamivir phosphate is an influenza neuraminidase inhibitor (NAI) used to treat and prevent influenza A and influenza B infections.
The medicine is approved for:
- Treatment of acute, uncomplicated influenza A and B in patients aged two weeks and older who have experienced symptoms for no more than 48 hours.
- Prevention of influenza A and B in patients aged one year and older.
Early treatment with oseltamivir can help reduce the severity and duration of flu symptoms, making it an important antiviral option during influenza seasons.
Approval Strengthens Alembic's U.S. Generics Portfolio
The latest FDA approval adds another product to Alembic's growing U.S. pipeline.
The company now holds a total of 243 ANDA approvals from the U.S. FDA, including:
- 223 final approvals
- 20 tentative approvals
This milestone reflects Alembic's continued focus on expanding its portfolio of affordable generic medicines for the U.S. market.
Growing Presence in the U.S. Pharmaceutical Market
Alembic Pharmaceuticals has been steadily increasing its footprint in the United States by securing approvals across multiple therapeutic categories. The latest approval for oseltamivir phosphate oral suspension further supports the company's strategy of bringing high-quality generic medicines to patients while strengthening its position in one of the world's largest pharmaceutical markets.
