Zevacor Announces FDA Approval of ANDA for Choline C11

Now producing radioisotope for clinical PET scans in Prostate cancer restaging

Noblesville, Indiana (November 17, 2015) – Zevacor Molecular (Zevacor), a healthcare firm that manufactures and distributes PET and SPECT radiopharmaceuticals, announced the approval of its abbreviated new drug application (ANDA) for Choline C11 Injection (Choline C11) by the U.S. Food and Drug Administration (USFDA).

Choline C11, a diagnostic radiopharmaceutical, is utilized in positron emission tomography (PET) imaging of patients with suspected prostate cancer recurrence following negative or inconclusive conventional imaging. In these patients Choline C11 PET or PET/CT may help identify potential sites of recurrence for subsequent histologic confirmation.

“We are pleased that this potentially powerful diagnostic tool will now be available to patients,” noted Peter Webner, Executive Vice President, Zevacor. “With a predicted 100,000 men in the U.S. pursuing subsequent therapy for prostate cancer relapse annually, an improved imaging test could make a significant impact on patient care.”1

“This product will initially be available through our Decatur, Illinois facility which has already been manufacturing clinical research doses,” said John Zehner, Executive Vice President and Chief Operating Officer, Zevacor. “Additional sites will be introduced during 2016, including radiopharmacies operated by our sister company IBA Molecular North America, Inc. Our Choline C11 PET service will include educational resources as well as onsite and online training to ensure quality scans and reports delivered to physicians and their patients.”

The initial USFDA-approved NDA for Choline C11 Injection is held by The Mayo Clinic in Rochester, Minnesota.

References: 1. National Cancer Institute Surveillance, Epidemiology & End Results Program (SEER) data on prostate cancer patients. Accessed at: http://seer.cancer.gov/statfacts/html/prost.html. November 6, 2015.

About Choline C11 Injection

Choline C11 Injection (Choline C11) is a radioactive diagnostic agent for positron emission tomography (PET) imaging of patients with suspected prostate cancer recurrence and non-informative bone scintigraphy, computerized tomography (CT) or magnetic resonance imaging. In these patients, Choline C11 PET imaging may help identify potential sites of prostate cancer recurrence for subsequent histologic confirmation. Suspected prostate recurrence is based upon elevated blood prostate specific antigen (PSA) levels following initial therapy. In clinical studies, images were produced with PET/CT co-registration. Limitation of Use: Choline C11 PET imaging is not a replacement for histologic verification of recurrent prostate cancer.

About Zevacor Molecular

Zevacor Molecular (Zevacor) is a U.S. healthcare firm that manufactures PET and SPECT radiopharmaceuticals. The company, established in 2012, is dedicated to providing medical isotopes to support the diagnosis and treatment of critical illnesses. Headquartered in Noblesville, Indiana, Zevacor is part of the Illinois Health and Science (IHS) family of companies, which includes Decatur Memorial Hospital, Integrated Health Network and IBA Molecular North America, Inc. (IBA). Zevacor and IBA, as affiliated radiopharmaceutical manufacturers, are committed to the IHS mission of enhancing the span, experience and quality of human life through improved patient care and outcomes.

More information can be found at www.zevacor.com

Full prescribing information for Choline C11 is available here


Peter Webner, Executive Vice President
Zevacor Molecular