Lupin Ltd has received US FDA approval for the ANDA for Cefixime Suspension 100mg/5ml. Earlier this month, the company also received approval for Cefixime Tablet 400 mg.
Wyeth marketed Cefixime 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.