Court Orders FDA to Suspend Approval of Bayer HealthCare Drug
Published: Apr 18, 2013
Enroflox 100, a new generic drug formulated for the treatment of bovine respiratory disease, is on hold pending a legal challenge over the U.S. Food and Drug Administration’s approval of the medication. The manufacturer, Norbrook Laboratories of Lenexa, Kan., received FDA approval March 29 of an Abbreviated New Animal Drug Application for Enroflox 100 (enrofloxacin), a generic version of Bayer HealthCare’s Baytril 100. Enroflox 100 and Baytril 100 were developed by Norbrook Laboratories and Bayer HealthCare, respectively. Bayer won a temporary restraining order April 12 that suspended the FDA’s approval of Enroflox and the label. Bayer, based in Shawnee Mission, Kan., contended that labeling the administration of Enroflox as a multiple-dose regimen would be ignored by practicing veterinarians, who instead would deliver a single high dose, harming sales of Baytril 100, which has single-dose approval.