EKR Therapeutics, a specialty pharmaceutical company focused on providing novel products for the acute-care hospital setting, announced that it received approval from the US Food and Drug Administration for Cardene IV (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.
EKR further noted that it will start taking orders immediately for the new RTU bags of Cardene I.V.
The RTU formulations significantly expand the Cardene franchise which has primarily consisted of sales of ampoules of Cardene IV. "Market acceptance and growth in utilization of Cardene have been strong in the past several years," noted Howard Weisman, EKR's Chairman & CEO. Based on data on file at EKR, over 900,000 patients have been treated with Cardene IV. since 2003.
"We expect the convenience and readiness of the intravenous bags to significantly complement and build upon the market success of the ampoules," said Weisman. "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 IV 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, along with Cardene IV, in 2005. The EKR team re-acquired the product line in early 2008.
EKR Therapeutics is a privately held specialty pharmaceutical company that has brought together a highly seasoned team of industry professionals. The company focuses on the acquisition, development and commercialization of proprietary products to enhance patient quality-of-life in the acute setting, including cardiovascular, pain management and oncology supportive care medications.