The Food & Drug Administration's Center for Veterinary Medicine announced April 16 that the U.S. District Court for the District of Columbia issued last Friday a temporary restraining order in Civil Action No. 13-487, suspending approval of Norbrook Inc.'s Abbreviated New Animal Drug Application No. 200-495 for Enroflox 100 (enrofloxacin) for treating cattle, suspending approval of the label for Enroflox 100 for treating cattle and directing FDA to notify all interested parties of this suspension until this matter is resolved.
Norbrook announced last month that FDA approved Enroflox 100 for multi-day use only in cattle and non-lactating dairy heifers less than 20 months of age and swine. Norbrook's product has the same active ingredient and formulation as Bayer Animal Health's Baytril 100 product.
Bayer AG sued FDA over the approval on April 10, seeking to block sales of the generic product due to concerns that the generic would be used in an off-label manner.
District court judge Rosemary M. Collyer issued the order for a temporary restrain order and set a hearing on the motion for April 25.