Business
Lantheus Receives U.S. FDA Approval of New Manufacturing Facility
On-site plant will produce DEFINITY® (Perflutren Lipid Microsphere), the leading diagnostic ultrasound enhancing agent for patients with suboptimal
About this update from Lantheus Holdings, Inc.
[{"type":"text","content":"On-site plant will produce DEFINITY® (Perflutren Lipid Microsphere), the leading diagnostic ultrasound enhancing agent for patients with suboptimal echocardiograms NORTH BILLERICA, Mass., Feb. 23, 2022 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. (the “Company”) (NASDAQ: LNTH), an established leader and fully integrated provider committed to innovative imaging diagnostics, targeted therapeutics and artificial intelligence solutions to Find, Fight and Follow serious medical conditions, announced today that the U.S. Food and Drug Administration (FDA) has approved the Supplemental Drug Application (sNDA) for the Company’s isolator-based drug manufacturing facility for DEFINITY® (Perflutren Lipid Microsphere), the leading diagnostic ultrasound enhancing agent in U.S. for patients with suboptimal echocardiograms. Lantheus constructed the specialized, in-house manufacturing facility at the Company’s North Billerica, Massachusetts headquarters for purposes of producing DEFINITY and potentially other sterile vial products. Designed and constructed with industry leading partners, the 16,000 sq. ft. facility utilizes a state-of-the-art manufacturing process and has the capacity to meet the Company’s current total demand for DEFINITY, while providing flexibility for potential future growth opportunities. “Achieving approval of our on-site manufacturing facility was a Company-wide effort and represents an important step forward for Lantheus’ strategy to improve the security of DEFINITY supply,” said Mary Anne Heino, President and Chief Executive Officer of Lantheus. “This facility will provide the Company with supply chain redundancy and the opportunity for margin expansion as we progressively include DEFINITY inventory from this facility into our supply chain. We intend to begin shipping DEFINITY from our on-site manufacturing facility to customers immediately.” About DEFINITY® DEFINITY Vial for (Perflutren Lipid Microsphere) Injectable Suspension (activated) is an ultrasound enhancing agent for use in patients with suboptimal echocardiograms (see Indications and Important Safety Information below and find full Prescribing Information at www.definityimaging.com).1 DEFINITY is engineered to produce small and consistently sized durable microbubbles to fully evaluate the left ventricle.1 DEFINITY has extensive safety experience and a consisten...