News | April 04, 2011

FDA Gives Complete Response Letter for PET Imaging Agent

April 4, 2011 – The U.S. Food and Drug Administration (FDA) has given a complete response letter to Eli Lilly and its subsidiary, Avid Radiopharmaceuticals, regarding the new drug application (NDA) for Amyvid (florbetapir F 18 injection). Amyvid is a Positron Emission Tomography (PET) imaging agent under investigation for the detection of beta-amyloid plaque in the brains of living patients.

The complete response was primarily focused on the need to establish a reader training program for market implementation that helps to ensure reader accuracy and consistency of interpretations of existing Amyvid scans.

"Lilly and Avid have been engaged in an active and ongoing dialogue with the FDA," said Wei-Li Shao, Lilly brand director for Amyvid. "We remain confident in the data submission package for Amyvid."

Since questions on the reader training program were raised by FDA reviewers late last year, the companies have been working to address these questions and will continue to do so in an ongoing dialogue with the FDA.

For more information: www.lilly.com

Related Content

Houston Methodist Hospital Enters Multi-Year Technology and Research Agreement With Siemens Healthineers
News | Imaging | August 17, 2017
Houston Methodist Hospital and Siemens Healthineers have entered into a multi-year agreement to bring cutting-edge...
Study Demonstrates First Human Application of Novel PET Tracer for Prostate Cancer

Transaxial 11Csarcosine hybrid PET/CT showed a (triangulated) adenocarcinoma in the transition zone of the anterior right prostate gland on PET (A), CT (B), and a separately obtained T2?weighted MR sequence (C) with resulting PET/MRI registration (D). Image courtesy of M. Piert et al., University of Michigan, Ann Arbor, Mich.

News | Radiopharmaceuticals and Tracers | August 16, 2017
In the featured translational article in the August issue of The Journal of Nuclear Medicine, researchers at the...
Patient Complexity, Subspecialization Impact List Prices for Radiologists' Services
News | Business | August 15, 2017
A new study by the Harvey L. Neiman Health Policy Institute finds that patient condition complexity and...
Upcoming radiology conferences, meetings and events.
News | August 14, 2017
ITN maintains a comprehensive listing of radiology specialty meetings on its website at ...
ACR Establishes Education Committee for Patient- and Family-Centered Care
News | Patient Engagement | August 09, 2017
Members of the new Education Committee of the American College of Radiology (ACR) Commission on Patient- and Family-...
ACR Annual Conference on Quality and Safety Offers Strategies for Radiology Practices
News | Business | August 08, 2017
The American College of Radiology (ACR) Annual Conference on Quality and Safety, scheduled for Oct. 13-14 in Boston,...
Sponsored Content | Videos | Business | July 28, 2017
Angelic McDonald, MSRS, CRA, FAHRA, regional director of imaging, Baylor Scott & White Health and the president-e
Radiation dose tracking in medical imaging is helping increase patient safety by lower X-ray doses.
Feature | Radiation Dose Management | July 26, 2017 | Dave Fornell
Patient X-ray radiation exposure from medical imaging has been a hot topic in radiology the past few years and has pr
Radiologists Seek Greater Involvement in Patient Care
News | Patient Engagement | July 20, 2017
Despite time and workload constraints, radiologists are looking for ways to become more directly involved in the care...
Overlay Init