While Lupin Ltd received marketing approval from the US Food and Drug Administration (US FDA) to market its Cefixime oral suspension drug in the US, Ranbaxy Laboratories has received approval to market two strengths of Cefprozil tablets and Cefprozil powder for oral suspension in Canada.Lupin said the USFDA has approved its anti-infective Suprax, the cefixime for oral suspension 200mg and 5ml. This novel formulation is a line extension of Lupin's flagship anti-infective brand Suprax.The higher concentration formulation allows parents to administer fewer teaspoons per dose of the antibiotic to children. When using the novel dose, parents would need to administer only half the volume of the existing 100mg or 5ml suspension."This important line extension allows us to increase our share of the cephalosporin oral suspension pediatric market. This market is currently valued at $625 million as per the data of IMS, December 2006. The incidence of respiratory infections is high in children and physicians need products that offer greater patient convenience and compliance. With this, Lupin has 19 abbreviated new drug application (ANDA) approvals till date," said Kamal Sharma, managing director, Lupin Ltd.According to Ranbaxy, it has received approval from the Canadian regulatory agency, Health Canada, to manufacture and market cefprozil tablets, 250mg and 500mg, and cefprozil powder for oral suspension, 250mg and 5ml. Ranbaxy markets its Cefprozil products under the brand name 'Ran'. The total market size for Cefzil, Bristol-Myers Squibb's original molecule of cefprozil, is CAD 28.2 million (Rs105 crore). It is indicated for the treatment of upper respiratory tract infections, uncomplicated skin and urinary tract infections.
