Sterility Issue Prompts Recall of Injectable Antiepileptic Drug
The recalled lots of Levetiracetam Injection 500mg per 5mL; NDC Number 25021-780-05, were distributed nationwide from March to November 2021.
General Neurology
Eprontia Oral Solution Approved for Partial-Onset, Primary Generalized Tonic-Clonic Seizures
Eprontia is approved for the treatment of partial-onset or primary generalized tonic-clonic seizures and migraine prevention.
Traumatic Brain Injury Tied to Later Opioid Use, Misuse
History of TBI tied to 52 percent increased odds of prescription opioid use, 65 percent increased odds of prescription opioid misuse
First-of-its-Kind Deep Brain Stimulation Directional Lead Approved
The system works with Medtronic’s Percept™ PC Neurostimulator.
NeuroSphere Virtual Clinic Allows for Remote Neuromodulation Therapy Management
Using the programmer app, clinicians are able to remotely prescribe new treatment settings to the patient’s neuromodulation device via cloud and Bluetooth-based technology.
FDA Clears Rapid Blood Test for Mild Traumatic Brain Injury
The test measures glial fibrillary acidic protein and ubiquitin carboxyl-terminal hydrolase L1, biomarkers present in blood plasma at elevated concentrations after a brain injury.
New Drug Application for Apomorphine Infusion Pump Submitted for Review
The NDA for SPN-830 is supported by data from an extensive development program that includes the phase 3 TOLEDO study and a supportive open-label study.
Enspryng, a Self-Administered Treatment for NMOSD, Gets FDA Approval
The FDA has approved Enspryng (satralizumab-mwge; Genentech) for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive.
Gadavist Imaging Bulk Package Approved for Multi-Patient Dosing
Gadavist® Imaging Bulk Package is supplied as 604.72mg/mL of gadobutrol in 30mL and 65mL multidose containers.
Aducanumab Gets Priority Review for Alzheimer Disease
The FDA has accepted for Priority Review the Biologics License Application for aducanumab (Biogen) for the treatment of Alzheimer disease.
