Court Orders FDA To Suspend Approval Of Norbrook’s New Bovine Drug
April 17, 2013
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. 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.,… Continue reading...