BALTIMORE, April 12 /PRNewswire/ -- Lupin Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (US FDA) has approved the company's application for Suprax(R) (Cefixime for oral suspension 200mg/5ml). Commercial shipments of the product have commenced.
This novel formulation of Suprax(R) 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.
Lupin Pharmaceuticals, Inc. is the U.S. wholly owned subsidiary of Lupin Limited, which is among the top five Pharmaceutical companies in India. Through its sales and marketing headquarters in Baltimore, Maryland, Lupin Pharmaceuticals, Inc. is dedicated to delivering high-quality, affordable medicines trusted by healthcare professionals and patients across geographies. For more information, visit http://www.lupinpharmaceuticals.com .
Safe Harbor Statement under the U. S. Private Securities Litigation Reform Act of 1995:
This release contains forward-looking statements that involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. Many of these risks, uncertainties and other factors include failure of clinical trials, delays in development, registration and product approvals, changes in the competitive environment, increased government control over pricing, fluctuations in the capital and foreign exchange markets and the ability to maintain patent and other intellectual property protection. The information presented in this release represents management's expectations and intentions as of this date.
Lupin expressly disavows any obligation to update the information presented in this release.
(R) SUPRAX is a registered trademark of Lupin Pharmaceuticals, Inc For More Information: Contact: Atul Gokhale General Manager - Marketing 410-576-2000
Lupin Pharmaceuticals, Inc.CONTACT: Atul Gokhale, General Manager, Marketing, of LupinPharmaceuticals, Inc., +1-410-576-2000
Web site: http://www.lupinpharmaceuticals.com/
