FDA accepts Rockwell’s application for IV Triferic

Rockwell Medical (NASDAQ:RMTI) is up 9% premarket on light volume in reaction to its announcement that the FDA has accepted for review its marketing application for an intravenous (IV) formulation of TRIFERIC (ferric pyrophosphate citrate), first approved in the U.S. in January 2015 as a hemodialysate (mixed with bicarbonate) for the maintenance of hemoglobin in dialysis patients. The IV formulation would allow dialysis centers to administer TRIFERIC to patients regardless of how bicarbonate is delivered.

The agency’s action date is March 28, 2020.

https://seekingalpha.com/news/3487533-fda-accepts-rockwells-application-iv-triferic-shares-9-percent-premarket