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Seizures News (Page 6)
Related terms: Complex Partial Seizure, Fits, Convulsion, Absence Seizure
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...
FDA Medwatch Alert: Lamotrigine Orally Disintegrating Tablet 200 mg by Impax: Recall - Incorrect Labeling of Blister Cards
ISSUE: Impax Laboratories, Inc. issued a voluntary nationwide retail level recall on August 19, 2016 for one lot of Lamotrigine Orally Disintegrating Tablet (ODT) 200 mg, NDC 0115-1529-08, Lot #...
Eisai Announces FDA Approval of Fycompa (perampanel) Oral Suspension
WOODCLIFF LAKE, N.J., May 2, 2016 /PRNewswire/ – Eisai Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved Fycompa (perampanel) CIII Oral Suspension as adjunctive...
FDA Approves Briviact (brivaracetam) to Treat Partial Onset Seizures
February 19, 2016 – The U.S. Food and Drug Administration yesterday approved Briviact (brivaracetam) as an add-on treatment to other medications to treat partial onset seizures in patients age 16...
FDA Medwatch Alert: Magnesium Sulfate in Water for Injection by Hospira: Recall - Incorrect Barcode Labeling on the Primary Container
ISSUE: Hospira, Inc. announced a voluntary recall of one lot of MAGNESIUM SULFATE IN WATER FOR INJECTION (0.325 mEq Mg**/mL) 40 mg/mL 2g total, 50 mL (NDC: 0409-6729-24, Lot 53-113-JT, Expiry...
FDA Approves Spritam (levetiracetam) as the First 3D Printed Drug Product
BLUE ASH, Ohio, August 3, 2015 – Aprecia Pharmaceuticals Company today announced that the U.S. Food and Drug Administration (FDA) has approved Spritam (levetiracetam) for oral use as a prescription...
FDA Approves Fycompa as Adjunctive Treatment for Primary Generalized Tonic-Clonic Seizures
Tokyo, June 22, 2015 – Eisai Co., Ltd. announced today that its U.S. subsidiary Eisai Inc. has received approval from the U.S. Food and Drug Administration (FDA) for an indication expansion...
FDA Medwatch Alert: Potiga (ezogabine): Drug Safety Communication - FDA Determines 2013 Labeling Adequate to Manage Risks of Retinal Abnormalities, Potential Vision Loss, and Skin Discoloration
ISSUE: Based on reviews of additional safety reports from patients treated with the anti-seizure drug Potiga (ezogabine), the FDA has determined that the potential risks of vision loss due to pigment...
FDA Approves Expanded Indication for Qudexy XR (Topiramate) for Pediatric Patients
Maple Grove, MN – June 1, 2015 – Upsher-Smith Laboratories, Inc. (Upsher-Smith) announced that it has received U.S. Food and Drug Administration (FDA) approval of a supplemental new drug application ...
Sun Pharma Announces FDA Approval of Elepsia XR (levetiracetam) Extended-Release Tablets
March 04, 2015, Mumbai: Sun Pharma Advanced Research Company Ltd. (SPARC) today announced that the U.S. Food and Drug Administration (FDA) has approved its New Drug Application (NDA) for Elepsia XR...
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