SPRINGFIELD, N.J.,Dec. 12, 2022/PRNewswire/ -- Evergreen Theragnostics has submitted a New Drug Application (NDA) for EVG-001 (Kit for preparation of Gallium-68 DOTATOC Injection), a radiopharmaceutical for imaging of neuroendocrine tumors using Positron Emission Tomography (PET), to the U.S. Food and Drug Administration (FDA). The FDA has accepted the application for review and granted a target approval date (PDUFA date) ofJuly 20, 2023.
"Gallium-68 DOTATOC imaging has been clinically used inEuropefor well over a decade," saidJames Cook, President & CEO of Evergreen Theragnostics. "TheUniversity of Iowatook an important step in 2019 by gaining FDA approval for their own NDA for Gallium-68 DOTATOC, produced locally at theUniversity of Iowa. If approved, this NDA will build on that by making Ga-68 DOTATOC imaging available nationwide for neuroendocrine tumor patients, in the form of an easy-to-use kit for radiopharmacies. We thank theUniversity of Iowafor leading the way in this space, as well as for their support and contribution to this application."
"It's very encouraging to see this move forward. The long-term goal of our work at theUniversity of Iowahas always been to make Ga-68 DOTATOC more widely available to patients in the US," saidJohn Sunderland, PhD, MBA, UI Professor of Radiology. "The efforts of Evergreen Theragnostics will almost certainly extend the availability of Gallium-68 DOTATOC to the neuroendocrine tumor patient population ofthe United States未来几年,延长主vision of the researchers here atIowa."
"This filing represents the first NDA for Evergreen Theragnostics, and an important step forward as we broaden our portfolio of offerings," said Mr. Cook. "This significant achievement complements our ongoing commitment to our core CDMO (Contract Development and Manufacturing Organization) business."
If approved, doses prepared using EVG-001 are expected to be available starting in Q3 2023 for purchase from Evergreen's radiopharmacy partners around the country.
Evergreen Theragnostics, established in 2019, is a US-based radiopharmaceutical company specialized in CDMO (Contract Development and Manufacturing Organization) services and commercialization of theragnostic radiopharmaceuticals. With a state-of-the-art global GMP facility inNew Jersey, Evergreen provides highly reliable manufacturing services for therapeutic and centrally distributed diagnostic radiopharmaceuticals, from early development through commercialization. The company was founded by a team that brings a strong track record in theragnostic radiopharmaceutical commercialization, manufacturing process development, and regulatory affairs management. For more information, please visitwww.evergreentgn.com.
For further information, please contact:
James Cook
President & CEO
[email protected]
SOURCE Evergreen Theragnostics, Inc.
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