Lupin gets USFDA approval for paediatric Suprax oral suspension
12 Apr 2007
Mumbai: Lupin Ltd has received US Food and Drug Administration (US FDA) approval for its Suprax Cefixime for oral suspension 200mg/5ml.
The Suprax formulation is an extension its anti-infective brand Suprax Cefixime oral suspension 100mg/5ml. The higher concentration formulation allows fewer teaspoons per dose of the antibiotic to children.
"The approval of our Cefixime for oral suspension product enables the launch of the extension of the brand Suprax in the US," said Kamal Sharma, managing director of the company.
USFDA approval for Suprax Cefixime would help Lupin increase its share in the paediatric market, the company said, adding, commercial shipments of the product have already started.
This is the company's 19th Abbreviated New Drug Application (ANDA) approval till date, Lupin informed the Bombay Stock Exchange.
"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," Sharma said.
This market is currently valued at $625 million (as per IMS, December 2006). The incidence of respiratory infections is high in children and physicians need products that offer greater patient convenience and compliance, Sharma added.