FDA’s approval of delafloxacin (BAXDELA) was announced on 20 June 2017 and the label can be found here. In brief, delafloxacin is a fluoroquinolone with coverage for MRSA as well as key Gram-negative pathogens.
The label is attached is worth reading as a good example of a modern label – reading closely will give you a feel for the breadth and depth of material that is required above and beyond the pivotal (Phase 3) program. Some reading notes are found below my signature (and with thanks to regulatory gurus Krissy Haeckl and Uzma Anwar for helping me proof same).
Congratulations to Eugene Sun and his team at Melinta on bringing this one to fruition!
John H. Rex, MD | Chief Medical Officer, F2G Ltd. | Chief Strategy Officer, CARB-X | Expert-in-Residence, Wellcome Trust
Follow me on Twitter: @JohnRex_NewAbx
Reading the BAXDELA label – a brief tour