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11 Feb 2013

FDA approval received for ultrasound imaging agent manufacturing site.

The FDA has approved Lantheus Medical's use of its JHS site for manufacturing of the ultrasound imaging agent Definitny Vial.

Lantheus Medical Imaging has announced that the US Food and Drug Administration (FDA) has approved a supplemental drug application (SNDA) that allows it to use Jubilant HollisterStier (JHS) as a manufacturing site for its ultrasound imaging agent Definity Vial for injectable suspension.

The manufacturer of diagnostic imaging agents has developed the ultrasound contact agent for use in patients with suboptimal echocardioagrams - it works to pacify the left ventricular chamber and improve the visual definition of its endocardial border.

Jeff Bailey, Lantheus president and chief executive officer, said: "FDA approval of JHS as a new manufacturer for Definity is a major step forward in providing consistent and reliable supply to our customers.

"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 the US, which announced in 2011 that it intends to exist the caontract manufacturing services business in the near-term.

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