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Seizures News (Page 5)
Related terms: Complex Partial Seizure, Fits, Convulsion, Absence Seizure
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...
Eisai Receives Approval for Antiepileptic Drug Banzel (rufinamide) As Adjunctive Treatment For Pediatric Patients
Tokyo, Japan – February 16, 2015 – Eisai Co., Ltd. announced today that its U.S. subsidiary Eisai Inc. has received approval of an additional pediatric indication for Eisai’s antiepileptic drug (...
Upsher-Smith Receives FDA Approval for Qudexy XR (topiramate) Extended-Release Capsules
Maple Grove, MN – March 12, 2014 – Upsher-Smith Laboratories, Inc. (Upsher-Smith), today announced it received approval on March 11, 2014 from the U.S. Food and Drug Administration (FDA) for Qudexy XR...
FDA Approves Aptiom to Treat Seizures in Adults
November 8, 2013 – The U.S. Food and Drug Administration today approved Aptiom (eslicarbazepine acetate) as an add-on medication to treat seizures associated with epilepsy. Epilepsy is a brain...
FDA Medwatch Alert: Potiga (Ezogabine): Drug Safety Communication - Linked To Retinal Abnormalities And Blue Skin Discoloration
UPDATED 11/01/2013: FDA approved changes to the drug label, underscoring risks of abnormalities to the retina in the eye, potential vision loss, and skin discoloration, all of which may become ...
FDA Medwatch Alert: Valproate Anti-Seizure Products: Drug Safety Communication - Contraindicated for Pregnant Women for Prevention of Migraine Headaches
Including valproate sodium (Depacon), divalproex sodium (Depakote, Depakote CP, and Depakote ER), valproic acid (Depakene and Stavzor), and their generics ISSUE: FDA is advising health care...
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