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Seizures News (Page 4)

Related terms: Complex Partial Seizure, Fits, Convulsion, Absence Seizure

FDA Approves Valtoco (diazepam nasal spray) as a Seizure Rescue Treatment

SAN DIEGO, CA – January 13, 2020 – Neurelis, Inc., today announced that the U.S. Food and Drug Administration (FDA) has approved Valtoco (diazepam nasal spray) as an acute treatment of intermittent, s...

FDA Approves Xcopri (cenobamate) for the Treatment of Partial-Onset Seizures in Adults

PANGYO, South Korea and PARAMUS, N.J., Nov. 21, 2019 /PRNewswire/ – SK Biopharmaceuticals, Co., Ltd., an innovative global pharmaceutical company focused on developing and bringing treatments to...

FDA Approves Nayzilam (midazolam) Nasal Spray to Treat Seizure Clusters

Brussels (Belgium) & Atlanta, Georgia (U.S.) – May 20 2019: UCB announced today that the U.S. Food and Drug Administration (FDA) has approved a New Drug Application for the company’s newest ant...

FDA Approves Sympazan (clobazam) Oral Film for Adjunctive Treatment of Seizures Associated with Lennox-Gastaut Syndrome

WARREN, N.J., Nov. 2, 2018 /PRNewswire/ – Aquestive Therapeutics, Inc. (NASDAQ: AQST), a specialty pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) approved...

FDA Approves Fycompa for the Treatment of Partial-Onset Seizures in Pediatric Patients as Young as 4 Years Old

WOODCLIFF LAKE, N.J., Sept. 28, 2018 /PRNewswire/ – Eisai Inc. announced today that the U.S. Food and Drug Administration (FDA) expanded the indication of its antiepileptic drug Fycompa (perampanel)...

FDA Approves Diacomit (stiripentol) for Seizures Associated with Dravet Syndrome

On August 20, 2018, the U.S. Food and Drug Administration (FDA) approved Diacomit (stiripentol) for seizures associated with Dravet syndrome in patients 2 years of age and older taking clobazam. ...

FDA Approves Epidiolex (cannabidiol) to Treat Lennox-Gastaut Syndrome and Dravet Syndrome

June 25, 2018 – The U.S. Food and Drug Administration today approved Epidiolex (cannabidiol) [CBD] oral solution for the treatment of seizures associated with two rare and severe forms of epilepsy,...

UCB Announces Briviact (brivaracetam) Now Approved by FDA to Treat Partial-Onset (Focal) Seizures in Pediatric Epilepsy Patients

Atlanta, Georgia (U.S.) & Brussels (Belgium), 0700 CEST, 14 May, 2018: UCB announced today that the U.S. Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) for...

FDA Approves Afinitor Disperz (everolimus) for Tuberous Sclerosis Complex-Associated Partial-Onset Seizures

April 11, 2018 – On April 10, 2018, the Food and Drug Administration approved everolimus tablets for oral suspension (Afinitor Disperz, Novartis Pharmaceuticals Corp.) for the adjunctive treatment...

FDA Medwatch Alert: Lamictal (lamotrigine): Drug Safety Communication - Serious Immune System Reaction

ISSUE: The FDA is warning that the medicine Lamictal (lamotrigine) for seizures and bipolar disorder can cause a rare but very serious reaction that excessively activates the body’s i...

Sunovion’s Aptiom (eslicarbazepine acetate) Receives FDA Approval for Expanded Indication to Treat Partial-Onset Seizures in Children and Adolescents 4 Years of Age and Older

MARLBOROUGH, Mass.--(BUSINESS WIRE)--September 14, 2017 Sunovion Pharmaceuticals Inc. (Sunovion) today announced that the U.S. Food and Drug Administration (FDA) approved the supplemental New Drug...

FDA Approves New indication for Briviact (brivaracetam) as Monotherapy Treatment of Partial-Onset Seizures in Adults

Atlanta, Georgia (U.S.) & Brussels (Belgium), 15 September, 2017 – 0700 (CEST): UCB announced today that the U.S. Food and Drug Administration (FDA) has approved a supplemental new drug application (...

FDA Approves Additional Use of Antiepileptic Drug Fycompa as Monotherapy for Partial-onset Seizures

July 27, 2017 Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) has announced that on July 26, 2017 (U.S. time), its U.S. subsidiary Eisai Inc. received approval from the U.S. Food and...

FDA Medwatch Alert: Phenobarbital 15 mg Tablets, USP by C.O. Truxton: Recall - Labeling Error on Declared Strength

ISSUE: C.O. Truxton, Inc. is voluntarily recalling lot 70952A of Phenobarbital Tablets, USP, 15 mg, to the consumer/user level. The manufacturer received a confirmed customer complaint that a bottle...

FDA Approves Carnexiv (carbamazepine) injection as Intravenous Short-Term Replacement Therapy for Certain Seizure Types

DEERFIELD, Ill.--(BUSINESS WIRE) October 07, 2016 --Lundbeck announced today that the U.S. Food and Drug Administration (FDA) has approved Carnexiv (carbamazepine) injection as a short-term...

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