EKR Therapeutics Broadens Its Ready-to-Use Cardene I.V. Product Offerings with FDA Approval of Double Concentration Premixed I.V. Bags
BEDMINSTER, N.J.--(BUSINESS WIRE)--Nov 11, 2008 - EKR Therapeutics, Inc., a specialty pharmaceutical company focused on providing novel products for the acute-care hospital setting, today announced that it received approval from the U.S. Food and Drug Administration (FDA) for double (2X) concentration Cardene I.V. (nicardipine hydrochloride) premixed injection.
These patented 200 ml ready-to-use (RTU) intravenous bags contain 40 mg of the calcium channel blocker nicardipine hydrochloride (0.2 mg/ml) in either dextrose or sodium chloride. The approval follows EKR's announcement on August 1, 2008 that the FDA had approved standard, or single (1X), concentration Cardene I.V. RTU bags The 1X preparations consist of 200 ml premixed bags containing 20 mg of nicardipine hydrochloride (0.1 mg/ml) in either dextrose or sodium chloride.
EKR noted that shipments of 1X Cardene I.V. RTU bags have already begun and that the Company is preparing to take orders for the new 2X preparations. The Company further noted that these premixed intravenous preparations support TJC (previously JCAHO) and ASHP standards to dispense medication in the most ready to administer form.
"Prior to the launch of the first premixed bags of Cardene I.V., the success of the product's franchise has been primarily fueled by sales of Cardene ampules, and the product has established an impressive 15 year legacy of effectively managing acute hypertensive episodes," noted Howard Weisman, EKR's Chairman and CEO. According to EKR estimations, the product has been administered to nearly a million patients. "We now have an exciting opportunity to build upon past successes of Cardene I.V. with the introduction of the premixed RTU bags," said Weisman.
In addition to convenience and the elimination of medication admixing errors, Cardene I.V. RTU bags enable immediate intervention in emergency settings. "Moreover, the breath of concentrations of our RTU Cardene I.V. products offers hospitals and healthcare providers with greater flexibility and utility in administering therapy under variety of point-of-care settings, ranging from the ambulance to emergency departments and through the operating room into the intensive care and post-operative units."
About EKR Therapeutics
EKR Therapeutics is a privately held specialty pharmaceutical company focused on identifying, fostering and targeting the growth of novel acute-care hospital products to improve outcomes and patient quality of life. Backed by the strength of its management team, the dedication of its field force of product specialists and its commitment to excellence in customer service and medical education, EKR has been organized to be a class leader in commercializing products to address unmet and under-satisfied medical needs or to otherwise enhance the therapeutic value of acute-care products. The Company's growing portfolio of specialty acute-care products includes Cardene(R) I.V. (nicardipine hydrochloride) premixed injection, Retavase(R) (reteplase recombinant), DepoDur(R) (morphine sulfate extended-release liposomal injection) and Gelclair(R) (bioadherent oral gel).
Posted: November 2008
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