FDA News

Lupin Receives US FDA Approval for Novel Formulation of Suprax Suspension

(April 12, 2007)-- Lupin Pharmaceuticals  announced  that the U.S. Food and Drug Administration (US FDA) has approved the company's application for Suprax (Cefixime for oral suspension 200mg/5ml). Commercial shipments of the product have commenced.

This novel formulation of Suprax is a line extension of Lupin's flagship anti-infective brand Suprax(R) (Cefixime for oral suspension 100mg/5ml). The higher concentration formulation allows parents to administer fewer teaspoons per dose of the antibiotic to their children. When using the novel dose, parents would need to administer only half the volume of the existing 100mg/5ml suspension.

"The approval of our Cefixime for oral suspension 200mg/5ml product allows us to increase our share of the cephalosporin oral suspension pediatric market. This market is currently valued at $625 Million (as per IMS, Dec 2006). The incidence of respiratory infections is high in children and physicians need products that offer greater patient convenience and compliance," said Vinita Gupta, President, Lupin Pharmaceuticals, Inc.

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