The FDA has granted approval of Lantheus Medical Imaging’s sNDA, allowing Jubilant HollisterStier (JHS) to be a new manufacturing site for its ultrasound imaging agent, DEFINITY Vial for (Perflutren Liquid Microsphere) Injectable Suspension.
“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 chief executive officer. “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 in Bedford, OH. In August 2011, Ben Venue announced plans to exit the contract manufacturing services business, which will take place during the next several years. In February 2012, Lantheus entered into a manufacturing and supply agreement with JHS for DEFINITY, as well as the manufacture and supply of Cardiolite and Neurolite, which are also manufactured by Ben Venue.