Lupin Ltd on April 12, 2007 has 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 Company's flagship anti-infective brand Suprax® 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 enables the launch of this important line extension to our brand Suprax® in the US and 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 Dr. Kamal Sharma, Managing Director of the Company.
This is the Company's nineteenth ANDA approval till date.
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