www.fdanews.com/articles/61835-orchid-receives-approval-for-generic-cefotaxime
ORCHID RECEIVES APPROVAL FOR GENERIC CEFOTAXIME
August 18, 2006
Orchid Chemicals and Pharmaceuticals has received approval from the FDA for three of its abbreviated new drug applications (ANDA) for cefotaxime injection in various dosage forms. These pertain to 500-mg, 1-g and 2-g single-dose vials.
Cefotaxime is the generic version of sanofi-aventis' antibiotic Claforan. The company is planning to launch this product in the U.S. through its exclusive distribution partner, Apotex.
Orchid has filed 31 ANDAs with the FDA to date, of which the agency has approved 15.