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FDA Approves Cefixime Suspension; Product to be Relaunched Under Suprax Brand
BALTIMORE, MD -- February 25, 2004 -- Lupin Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (USFDA) has approved Lupin Ltd.'s Abbreviated New Drug Application (ANDA) for Cefixime Suspension 100mg/5ml. Earlier this month, Lupin received approval for its Cefixime Tablet 400 mg ANDA.
Lupin is the first company with an ANDA approval for Cefixime. Cefixime was marketed by Wyeth until March 2003 under the Suprax® brand. Lupin will relaunch the product under the Suprax trademark that Lupin has licensed on an exclusive basis for the US market. The market size of Suprax in the US was $51 million (MAT Dec 2002).
Lupin Chairman Dr. Desh Bandhu Gupta said, "The approval of this important product marks Lupin's entry into the US market for branded finished products. The launch of this product would further strengthen Lupin's position in the cephalosporins business in the US. Developing a range of value-added products for the developed markets, based on our strengths in drug delivery systems, is a core strategic thrust for Lupin."
Lupin is creating a specialty pediatric sales force and will launch Suprax in the US shortly, through its wholly owned subsidiary, Lupin Pharmaceuticals, Inc. With this approval, Lupin now has 5 ANDAs approved by the USFDA. Earlier in this financial year, Lupin received USFDA approval for Cefuroxime Axetil Tablets, Cefotaxime vials for Injection and Ceftriaxone vials for Injection.
Further information on the product is available on http://www.suprax.info.
SOURCE Lupin Pharmaceuticals, Inc
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