Published on April 15, 2007 at 5:52 AM
Lupin Pharmaceuticals 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 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 $625 Million (as per IMS, Dec 2006). The incidence of respiratory infections is high in children and physicians need products that offer greater patient convenience and compliance," said Vinita Gupta, President, Lupin Pharmaceuticals, Inc.
This is Lupin's 19th ANDA approval by US FDA to date. About Lupin
Headquartered in Mumbai, Lupin Ltd. is a leading pharmaceutical company with strong research focus. It has a program for developing New Chemical Entities. The Company has state-of-the-art R&D center in Pune. The Company is a leading global player in Anti-TB, Cephalosporins (anti-infectives) and Cardiovascular drugs (prils and statins) and has a notable presence in the areas of diabetology, NSAIDs and Asthma.
For the nine-month period ended December 2006, the Company's Revenues and Profit after Tax were Rs.14,985 million (US$ 335 million) and Rs.1,650 million (US$ 37 million) respectively.
http://www.lupinpharmaceuticals.com/