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Neuraceq FDA Approval History

Last updated by Judith Stewart, BPharm on July 14, 2025.

FDA Approved: Yes (First approved March 19, 2014)
Brand name: Neuraceq
Generic name: florbetaben F18
Dosage form: Injection
Company: Life Molecular Imaging, Ltd.
Treatment for: Positron Emission Tomography Imaging

Neuraceq (florbetaben F18) is a radioactive diagnostic agent indicated for PET imaging of the brain to estimate β-amyloid neuritic plaque density.

Development timeline for Neuraceq

DateArticle
Jun 30, 2025Approval FDA Expands Indications for Neuraceq, an Amyloid PET Imaging Agent, to Enhance Diagnosis and Care of Patients with Alzheimer’s Disease
Mar 20, 2014Approval FDA Approves Neuraceq (florbetaben F18 injection) for PET Imaging of Beta-Amyloid Plaques

Further information

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