Evergreen Theragnostics Submits New Drug Application for Gallium-68 DOTATOC Kit with US FDA
SPRINGFIELD, NJ, December 5, 2022 – 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) of July 20, 2023.
“Gallium-68 DOTATOC imaging has been clinically used in Europe for well over a decade,” said James Cook, President & CEO of Evergreen Theragnostics. “The University of Iowa took an important step in 2019 by gaining FDA approval for their own NDA for Gallium-68 DOTATOC, produced locally at the University 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 the University of Iowa for 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 the University of Iowa has always been to make Ga-68 DOTATOC more widely available to patients in the US,” said John 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 of the United States for future years to come, extending the primary vision of the researchers here at Iowa.”
“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.
About Evergreen Theragnostics, Inc.
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 in New 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 visit www.evergreentgn.com.
For further information, please contact:
James Cook
President & CEO