FDA Approves New Cardene Formulation
FDA Approves New Cardene Formulation
CEDAR KNolls, NJ, Aug. 1, 2008-EKR Therapeutics, Inc., a specialty pharmaceutical company focused on providing novel products for the acute-care hospital setting, today announced that it received FDA approval for Cardene I.V. (nicardipine hydrochloride) premixed injection, a patented, ready-to-use (RTU), single use intravenous bag for the administration of this calcium channel blocker. The 200 ml RTU bags contain 20 mg of the anti-hypertensive agent nicardipine hydrochloride (0.1 mg/ml) in either dextrose or sodium chloride.
The RTU formulations significantly expand the Cardene franchise which has primarily consisted of sales of Cardene I.V. ampoules. "We expect the convenience and readiness of the intravenous bags to significantly complement and build upon the market success of the Cardene I.V. ampoules," said Howard Weisman, EKR's Chairman & CEO. EKR estimates that over 900,000 patients have been treated with Cardene I.V. since 2003. "With the addition of the ready-to-use bags, the breadth of our Cardene product offerings has expanded greatly and we foresee opportunities for wider utilization of this anti-hypertensive across a range of acute-care settings."
Weisman concluded by noting, "This is a particularly exciting event for EKR, because many of us were part of the original team at ESP Pharma that identified, acquired, and relaunched Cardene I.V. [ampoules] on what has since proved to be a road of successful growth." Weisman cofounded ESP Pharma in 2002 and that company was acquired by PDL BioPharma (PDLI) in 2005. The EKR team re-acquired the product line in early 2008.
Posted: August 2008
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- EKR Therapeutics Broadens Its Ready-to-Use Cardene I.V. Product Offerings with FDA Approval of Double Concentration Premixed I.V. Bags - November 11, 2008
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