Cadila gets USFDA nod for marketing 3 drugs
Mumbai, June 12 (PTI): Cadila Healthcare today announced that it has received US Food and Drug Administration (USFDA) approval for marketing its three products in the US.
"The group will market all three drugs through its US subsidiary Zydus Pharmaceuticals (USA) Inc. The group now has 27 approvals since the commencement of filing process in FY 2003-04," the pharma company said in the communique to the BSE.
The company has received approvals to market Benzonatate Tablets of 100mg and 200mg strength, Naproxen Tablets and tentative approval for Amlodipine Besylate Tablets 2.5 mg, 5 mg and 10 mg strengths, the health-care solutions provider said in a filing to the Bombay Stock Exchange.
The branded sales in the US market of Benzonatate Tablets, which falls in the cough-suppressant segment, was estimated at 134 million dollar in 2006 as per National Drug Code (NDC).
The sales of Amlodipine Besylate Tablets, an anti-hypertensive, was estimated at $ 2.74 billion in 2006 and that of Naproxen Tablets, which falls in the analgesic segment, was estimated at 0.67 billion dollar in 2006 as per NDC Health.
Shares of the company dipped 0.33 per cent at Rs 336.20 in the morning trade on the BSE.
Business