Ekr Therapeutics Wins FDA Approval for Double Concentration Premixed IV Bags

Ekr Therapeutics, a specialty pharmaceutical company, has received the FDA approval for double concentration Cardene IV premixed injection.

These patented 200ml ready-to-use (RTU) intravenous bags contain 40mg of the calcium channel blocker nicardipine hydrochloride (0.2mg/ml) in either dextrose or sodium chloride.

Previously, the company received the FDA approval for standard, or single (1X), concentration Cardene IV RTU bags. The 1X preparations consist of 200ml premixed bags containing 20mg of nicardipine hydrochloride (0.1mg/ml) in either dextrose or sodium chloride.

Ekr has said that the shipments of 1X Cardene IV RTU bags have already begun and that the company is preparing to take orders for the new double concentration preparations. The company further noted that these premixed intravenous preparations support TJC and the American Society of Health-System Pharmacy standards to dispense medication in the most ready to administer form.

Howard Weisman, chairman and CEO of Ekr, said: “Prior to the launch of the first premixed bags of Cardene IV, the success of the product’s franchise has been primarily fueled by sales of Cardene ampules, and the product has established a 15 year legacy of effectively managing acute hypertensive episodes. We now have an exciting opportunity to build upon past successes of Cardene IV with the introduction of the premixed RTU bags.”