Cadila gets US FDA nod for three products

New Delhi, June 12: Cadila Healthcare Ltd today said it has received US Food and Drug Administration (FDA) approvals to market Benzonatate Tablets and Naproxen Tablets in the strength of 100mg and 200 mg.

The company also received a tentative approval for Amlodipine Besylate Tablets in the strength of 2.5 mg, 5 mg and 10 mg.

The branded sales in the US market of Benzonatate Tablets, which falls in the cough-suppresant segment, was estimated at 134 million dollars in 2006 as per National Drug Code (NDC).

The branded sales of Amlodipine Besylate Tablets, an anti-hypertensive, was about 2.74 billion dollars in 2006 and that of Naproxen Tablets, an analgesic stood at 0.67 billion dollars in 2006, according to NDC Health.

The group will market all the three drugs through its US-subsidiary Zydus Pharmaceuticals (US) Inc.

UNI