Generalized Tonic-clonic Seizures
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CLINICAL_TRIALS trial_result · 2019-08-28Clinical Trial Update: A Safety, Efficacy and Tolerability Trial of Pregabalin as Add-On Treatment in Pediatric and Adult Subjects With Primary Generalized Tonic-Clonic (i.e., Grand Mal) Seizures. [Phase 3]
Phase 3 trial evaluating pregabalin as add-on therapy for pediatric and adult generalized tonic-clonic seizures has completed with results p…
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CLINICAL_TRIALS trial_result · 2018-07-10Clinical Trial Update: Detecting Generalized Tonic-Clonic Seizures With a Seizure Detection and Warning System in Epilepsy Patients
Completed clinical trial evaluating Brain Sentinel's Seizure Detection and Warning System for detecting generalized tonic-clonic seizures in…
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FDA approval · 2018-03-08FDA Approved: FOSPHENYTOIN SODIUM — Supplemental Application (West-Ward Pharmaceuticals Corp)
FDA approved a supplemental application for fosphenytoin sodium submitted by West-Ward Pharmaceuticals Corp. The action updates labeling for…
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FDA approval · 2017-08-14FDA Approved: LEVETIRACETAM — Supplemental Application (Aurobindo Pharma Limited)
FDA approved a supplemental application to authorize Aurobindo Pharma Limited to manufacture levetiracetam (generic) in the United States.
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CLINICAL_TRIALS trial_result · 2017-07-12Clinical Trial Update: Seizure Detection and Warning System in Epilepsy Patients
The Brain Sentinel seizure detection and warning system clinical trial for epilepsy patients has completed.
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FDA approval · 2017-06-09FDA Approved: LEVETIRACETAM — Supplemental Application (Prasco Laboratories)
FDA approves a supplemental application for levetiracetam by Prasco Laboratories, enabling a generic version to be marketed.
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CLINICAL_TRIALS trial_result · 2017-03-09Clinical Trial Update: An Open Label Study of L059 (Levetiracetam) in Japanese Epilepsy Subjects With Generalized Tonic-clonic Seizures [Phase 3]
This is a completed Phase 3 open-label study of levetiracetam (L059) in Japanese epilepsy patients with generalized tonic-clonic seizures. R…
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CLINICAL_TRIALS trial_result · 2017-03-09Clinical Trial Update: Study to Investigate Dosage, Efficacy, and Safety of Perampanel Given as Monotherapy in Patients With Epilepsy
This entry notes a completed clinical trial evaluating the dosage, efficacy, and safety of perampanel as monotherapy in patients with epilep…
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FDA approval · 2016-09-16FDA Approved: LEVETIRACETAM — Original Application (Mylan Institutional LLC)
FDA approved an original ANDA for levetiracetam from Mylan Institutional LLC, enabling a generic version of the anticonvulsant to reach the …
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CLINICAL_TRIALS trial_result · 2016-01-11Clinical Trial Update: A Efficacy and Safety Study of Adjunctive Perampanel in Primary Generalized Tonic Clonic Seizures [Phase 3]
Phase 3 trial evaluating adjunctive perampanel for primary generalized tonic-clonic seizures has completed; results were posted in 2016.
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FDA approval · 2015-12-14FDA Approved: LEVETIRACETAM — Supplemental Application (Prasco Laboratories)
The FDA approved a supplemental application for Levetiracetam from Prasco Laboratories, resulting in updated labeling for this antiepileptic…
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FDA approval · 2015-10-02FDA Approved: LEVETIRACETAM — Supplemental Application (Amneal Pharmaceuticals LLC)
The FDA approved Amneal Pharmaceuticals LLC's supplemental application for levetiracetam, a generic form of the antiepileptic drug, under up…
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FDA approval · 2015-08-13FDA Approved: LEVETIRACETAM — Original Application (Fresenius Kabi USA, LLC)
The FDA approved Fresenius Kabi USA, LLC's generic levetiracetam, expanding access to an anticonvulsant used to treat various seizure disord…
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FDA approval · 2015-06-19FDA Approved: FYCOMPA — Supplemental Application (Eisai Inc.)
The FDA approved a supplemental application for FYCOMPA (perampanel) from Eisai Inc., resulting in an updated labeling for the drug.
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FDA approval · 2015-06-04FDA Approved: LEVETIRACETAM — Original Application (Major Pharmaceuticals)
FDA approved the Original Application for levetiracetam from Major Pharmaceuticals, making a generic version of the anticonvulsant available…
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CLINICAL_TRIALS trial_result · 2015-05-13Clinical Trial Update: A Double-blind, Placebo-controlled Study of Levetiracetam in Epilepsy Patients With Generalized Tonic-clonic Seizures (Except Partial Seizures Evolving to Secondarily Generalized Seizures) [Phase 3]
Phase 3 double-blind, placebo-controlled trial evaluating Levetiracetam in epilepsy patients with generalized tonic-clonic seizures has comp…
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FDA approval · 2014-09-25FDA Approved: LEVETIRACETAM — Supplemental Application (Civica, Inc.)
FDA approved a Civica, Inc. supplemental application for Levetiracetam, approving changes to the generic product. The product is indicated f…
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FDA approval · 2014-08-07FDA Approved: KEPPRA — Supplemental Application (UCB, Inc.)
The FDA approved a supplemental application for KEPPRA (levetiracetam) from UCB, Inc., potentially expanding labeling or indications.
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FDA approval · 2013-08-07FDA Approved: LEVETIRACETAM — Supplemental Application (WG Critical Care, LLC)
The FDA approved a supplemental application for levetiracetam submitted by WG Critical Care, LLC.
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FDA approval · 2013-07-25FDA Approved: KEPPRA XR — Supplemental Application (UCB, Inc.)
FDA approved a supplemental application for KEPPRA XR (levetiracetam) submitted by UCB, Inc.
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FDA approval · 2013-06-30FDA Approved: FYCOMPA — Supplemental Application (Eisai Inc.)
The FDA approved Eisai's supplemental application for FYCOMPA (perampanel), resulting in changes to the product labeling.
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FDA approval · 2013-02-27FDA Approved: LEVETIRACETAM — Supplemental Application (QUAGEN PHARMACEUTICALS LLC)
FDA approved a supplemental application for levetiracetam by Quagen Pharmaceuticals LLC.
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FDA approval · 2012-04-26FDA Approved: LEVETIRACETAM — Supplemental Application (Dr. Reddy's Laboratories Limited)
FDA approved a supplemental application for Levetiracetam by Dr. Reddy's Laboratories Limited under the ANDA, reflecting an approved additio…
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FDA approval · 2012-04-26FDA Approved: LEVETIRACETAM — Supplemental Application (Aurobindo Pharma Limited)
The FDA approved a supplemental application for levetiracetam by Aurobindo Pharma Limited, approving this generic product under the ANDA.
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FDA approval · 2012-04-11FDA Approved: LEVETIRACETAM — Original Application (QUAGEN PHARMACEUTICALS LLC)
FDA approved the original application for levetiracetam by Quagen Pharmaceuticals LLC, making a generic version of the antiepileptic availab…