FDA Approves Jubilant HollisterStier as New Manufacturer for Definity Ultrasound Contrast Agent
March 14, 2013 — Lantheus Medical Imaging Inc. announced the U.S. Food and Drug Administration (FDA) has granted approval of a supplemental new drug application (sNDA) that allows Jubilant HollisterStier (JHS) to be a new manufacturing site for its ultrasound imaging agent, Definity Vial for (Perflutren Lipid Microsphere) Injectable Suspension.
Definity is an ultrasound contrast agent for use in patients with suboptimal echocardiograms to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border.
“FDA approval of JHS as a new manufacturer for Definity is a major step forward in providing consistent and reliable supply to our customers,” said Jeff Bailey, Lantheus president and CEO. “Supply chain diversification is a significant priority for the company as we work to ensure long-term product availability to meet market demand. We remain dedicated to providing the highest quality products to our customers and the patients they serve.”
Definity is currently manufactured by Ben Venue Laboratories (BVL) in Bedford, Ohio. In August 2011, BVL announced it would exit the contract manufacturing services business over the next several years. In February 2012, Lantheus entered into a manufacturing and supply agreement with JHS for the manufacture of Definity. Additionally, the company entered into similar agreements with JHS in May 2012 for the manufacture and supply of Cardiolite and Neurolite, which are also currently manufactured by BVL. JHS will become Lantheus’s lead supplier of Definity, as well as Cardiolite and Neurolite, as BVL transitions out of the contract manufacturing services business. Lantheus is currently working to secure additional alternative suppliers for its key products as part of its ongoing supply chain diversification strategy.
For more information: www.definityimaging.com