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FDA approves Jubilant HollisterStier site for Definity production

The FDA has approved Jubilant HollisterStier (JHS) manufacturing site for the production of Lantheus Medical Imaging's Definity vial for (perflutren liquid microsphere) injectable suspension.

The ultrasound contrast agent Definity is indicated for use in patients with suboptimal echocardiograms to opacify the left ventricular chamber and to recover the delineation of the left ventricular endocardial border.

Lantheus president and chief executive officer Jeff Bailey said, "Supply chain diversification is a significant priority for the Company as we work to ensure long-term product availability to meet market demand."

At present, Ben Venue Laboratories (BVL) is manufacturing Definity in Bedford, Ohio.

As BVL transits out of the contract manufacturing services operations, JHS will become the lead manufacturer of Lantheus’ Definity, in addition to Cardiolite and Neurolite.