Ceftin generic approved

Executive Summary

FDA approves Ranbaxy's ANDA for 125 mg, 250 mg and 500 mg tablets of cefuroxime axetil Feb. 20. The approvals were cleared by FDA's denial of petitions for a stay of cefuroxime approvals filed by GlaxoSmithKline and PDI. "Ranbaxy has met its burden" to show that the partially crystalline cefuroxime axetil in its product is the 'same' as the amorphous cefuroxime axetil in GSK's Ceftin, FDA said. Patent infringement litigation brought in October 2000 continues over the 4,562,181 Ceftin patent (1"The Pink Sheet" Aug. 20, 2001, p. 17)...