Partial-Onset Seizures

SK life science Presents Long-term Data on Cognitive and Psychiatric Adverse Events Associated with XCOPRI CV in Adults with Partial-Onset (Focal) Seizures at the AAN 2022 Annual Meeting

American Academy of Neurology (AAN) Annual Meeting, Central Nervous System Diseases, Clinical Studies, Clinical Trials, Epilepsy, Oncology, Partial-Onset Seizures, R&D

SK Life Science Inc., a subsidiary of SK Biopharmaceuticals Co. Ltd. – an innovative global pharmaceutical company focused on developing treatments for central nervous system (CNS) disorders – will present data from a pooled analysis from studies C013/C017 OLEs and C021 evaluating the cognitive and psychiatric treatment-related adverse events during adjunctive treatment with anti-seizure medication XCOPRI® (cenobamate tablets) CV at the American Academy of Neurology Annual Meeting, held in-person in Seattle April 2–7, 2022.

March 31, 2022/by PR Newswire

FDA Greenlights Xcopri for Partial-Onset Seizures

Approvals, CNS, Drug Enforcement Agency (DEA), Epilepsy, FDA, FDA/Regulatory, Partial-Onset Seizures, U.S. Centers for Disease Control and Prevention

SK Biopharmaceuticals and U.S. subsidiary SK Life Science announced that the U.S. Food and Drug Administration approved Xcopri (cenobamate tablets) for partial-onset seizures in adults.

November 22, 2019/by BioSpace

InvaGen Receives FDA Approval for Generic of Pfizer’s Lyrica

Approvals, FDA, FDA/Regulatory, Fibromyalgia, Generics, Neuropathic Pain, Partial-Onset Seizures, Postherpetic Neuralgia

The U.S. FDA approved InvaGen Pharmaceuticals’ generic version of Pfizer’s Lyrica (pregabalin) for eight different dosages.

July 22, 2019/by BioSpace

Eisai Submits Fycompa Pediatric Indications to FDA

FDA/Regulatory, Generalized Seizures, New Indications, Partial-Onset Seizures, Pediatric, Priority Review

Eisai Inc. submitted a supplemental New Drug Application for priority review to the U.S. FDA for the company’s antiepileptic drug Fycompa (perampanel) CIII as monotherapy and adjunctive use.

March 30, 2018/by PR Newswire

FDA Approves VNS Therapy Treatment

Approvals, Drug-Resistant Epilepsy, FDA, FDA/Regulatory, Medical Devices, Partial-Onset Seizures

FDA approved LivaNova’s VNS Therapy system in patients as young as 4 years of age with partial-onset seizures that are refractory to antiepileptic medications.

June 29, 2017/by Business Wire

Votubia receives EU approval for new indication

Approvals, EMA, FDA/Regulatory, Genetic Disorders, Health, New Indications, Partial-Onset Seizures, Seizures, Tuberous Sclerosis Complex (TSC)

Novartis broadened the indications for its Votubia drug with EU approval of its use to treat refractory partial-onset seizures in patients with tuberous sclerosis complex.

January 31, 2017/by Reuters Health