Lupin Ltd has received US FDA approval for its application of Suprax Cefixime for oral suspension 200mg/5ml. Commercial shipments of the product have commenced. Suprax Cefixime is the company's nineteenth ANDA approval till date.
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.
Dr Kamal Sharma, managing director, said, "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 paediatric 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."