FDA Actions
The Senate has confirmed Robert Califf, MD, as the new FDA commissioner. Dr. Califf, a cardiologist, was previously on the faculty of the Duke Medical School as vice chancellor for clinical and translational research. More recently, he was the FDA’s deputy commissioner for medical products and tobacco.
The FDA has approved brivaracetam as adjunctive treatment for partial onset seizures in patients ≥ 16 years of age. The drug is an analogue of the already-available antiepileptic drug levetiracetam. Approval was based on three clinical trials of 1550 participants that showed the drug was effective in reducing the frequency of seizures. Common side effects include drowsiness, dizziness, fatigue, and gastrointestinal symptoms. The drug also comes with a medication guide for patients regarding depression and suicidal thoughts. Brivaracetam is marketed as Briviact.
In this section: Senate confirms new FDA commissioner, and the FDA approves brivaracetam as adjunctive treatment for partial onset seizures.
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