FDA approves manufacturing site for Definity

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The FDA has approved Jubilant HollisterStier (JHS) as a manufacturing site for Lantheus Medical Imaging’s ultrasound imaging agent Definity Vial for 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.

Currently, Definity is manufactured by Ben Venue Laboratories in Bedford, Ohio. In August 2011, Ben Venue announced that it will exit the contract manufacturing services business over the next several years. In February 2012, North Billerica, Mass.-based Lantheus entered into a manufacturing and supply agreement with JHS for the manufacture of Definity. 

Lantheus entered into similar agreements with JHS in May 2012 for the manufacture and supply of Cardiolite and Neurolite, which are also currently manufactured by Ben Venue.

JHS will become the lead supplier of Definity, as well as Cardiolite and Neurolite, as Ben Venue transitions out of the contract manufacturing services business, Lantheus said in a press release.