Status Epilepticus
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Sign up freeTop drugs studied for this disease
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FDA approval · 2016-05-16FDA Approved: FOSPHENYTOIN — Supplemental Application (Fresenius Kabi USA, LLC)
FDA approved a supplemental application for fosphenytoin sodium from Fresenius Kabi USA, LLC under an existing ANDA.
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FDA approval · 2016-05-02FDA Approved: DIAZEPAM INTENSOL — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
The FDA approved a supplemental application for Diazepam Intensol from Hikma Pharmaceuticals USA Inc., confirming changes to the approved pr…
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FDA approval · 2016-04-18FDA Approved: LORAZEPAM — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
The FDA approved a supplemental application for Lorazepam from Hikma Pharmaceuticals USA Inc., indicating an approved update to the drug's l…
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FDA approval · 2016-03-03FDA Approved: CEREBYX — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)
The FDA approved a supplemental application for Cerebyx (fosphenytoin sodium) submitted by Pfizer Laboratories Div Pfizer Inc.
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CLINICAL_TRIALS trial_result · 2016-01-01Clinical Trial Update: Assessment of Severity and Prognosis for Patients With Status Epileptics(SE)
This document provides an update on a clinical trial evaluating the severity and prognosis of patients with status epilepticus. It outlines …
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FDA approval · 2015-03-09FDA Approved: DIAZEPAM — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
FDA approved a Teva supplemental application for Diazepam, resulting in an approved labeling change under ANDA 071321.
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CLINICAL_TRIALS trial_result · 2015-03-06Clinical Trial Update: Prevalence of Acute Critical Neurological Disease in Children: a Global Epidemiological Assessment
This completed epidemiological trial assesses the global prevalence of acute critical neurological diseases in children, including cardiac a…
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FDA approval · 2014-07-03FDA Approved: DILANTIN — Supplemental Application (Viatris Specialty LLC)
FDA approved a supplemental application for Dilantin (extended phenytoin sodium) by Viatris Specialty LLC. The approval concerns the extende…
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FDA approval · 2014-06-12FDA Approved: CEREBYX — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)
FDA approved a supplemental application for Cerebyx (fosphenytoin sodium) from Pfizer Laboratories Div Pfizer Inc.
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FDA approval · 2014-06-09FDA Approved: CEREBYX — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)
The FDA approved a supplemental application for Cerebyx (fosphenytoin sodium) submitted by Pfizer Laboratories Div Pfizer Inc.
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FDA approval · 2014-05-13FDA Approved: LORAZEPAM — Supplemental Application (Hospira, Inc.)
The FDA approved a supplemental application for lorazepam by Hospira, Inc.
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FDA approval · 2014-01-03FDA Approved: CEREBYX — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)
FDA approved a supplemental application for Cerebyx (fosphenytoin sodium) submitted by Pfizer Laboratories Div Pfizer Inc.
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FDA approval · 2013-09-25FDA Approved: FOSPHENYTOIN SODIUM — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approved a supplemental application for fosphenytoin sodium by Hikma Pharmaceuticals USA Inc., approving changes to the approved product…
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CLINICAL_TRIALS trial_result · 2013-04-04Clinical Trial Update: Treatment of Refractory Status Epilepticus [Phase 3]
A Phase 3 clinical trial for treatment of refractory status epilepticus was terminated, with results posted.
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CLINICAL_TRIALS trial_result · 2013-03-12Clinical Trial Update: Refractory Status Epilepticus Treatment Study [Phase 3]
Phase 3 trial evaluating a treatment for refractory status epilepticus (grand mal and non-convulsive forms) has completed.
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FDA approval · 2013-01-28FDA Approved: DIAZEPAM — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
FDA approved a supplemental application for diazepam from Teva Pharmaceuticals USA, Inc. The action represents an additional approval or mod…
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CLINICAL_TRIALS trial_result · 2012-12-18Clinical Trial Update: Efficacy and Safety Study Comparing Lorazepam and Diazepam for Children in the Emergency Department With Seizures (Status 2) [Phase 2, Phase 3]
Completed Phase 2/3 trial comparing lorazepam and diazepam for efficacy and safety in children in the emergency department with seizures.
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FDA approval · 2012-09-13FDA Approved: LORAZEPAM — Supplemental Application (International Medication Systems, Limited)
FDA approved a supplemental application for lorazepam from International Medication Systems, Limited.
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CLINICAL_TRIALS trial_result · 2012-07-10Clinical Trial Update: Randomized Trial Comparing 3 Routes of Delivering Lorazepam to Children. [Phase 3]
A Phase 3 randomized trial comparing three routes of delivering lorazepam to children with seizures has been terminated.
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CLINICAL_TRIALS trial_result · 2012-04-13Clinical Trial Update: Paramedic Treatment of Prolonged Seizures by Intramuscular Versus Intravenous Anticonvulsant Medications [Phase 3]
Phase 3 clinical trial comparing intramuscular versus intravenous anticonvulsants for treatment of prolonged seizures by paramedics; results…
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CLINICAL_TRIALS trial_result · 2012-03-02Clinical Trial Update: Putting Electroencephalography (EEG) in the Emergency Department
Completed trial evaluating the utility of emergency department electroencephalography (EEG) in patients with altered mental status and suspe…
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CLINICAL_TRIALS research · 2010-12-31Clinical Trial Update: Safety and Efficacy of Intravenous Valproate in Pediatric Status Epilepticus and Acute Repetitive Seizures
Clinical trial update evaluating the safety and efficacy of intravenous valproate in children with status epilepticus and acute repetitive s…
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FDA approval · 2010-06-15FDA Approved: LORAZEPAM — Original Application (Pharmaceutical Associates, Inc.)
FDA approved Lorazepam under an Original Application for an ANDA held by Pharmaceutical Associates, Inc., establishing a generic version of …
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FDA approval · 2009-12-23FDA Approved: LORAZEPAM — Original Application (Amneal Pharmaceuticals LLC)
FDA approves Amneal Pharmaceuticals' generic lorazepam (oral) under an Original Application (ANDA 091383).
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FDA approval · 2009-12-02FDA Approved: FOSPHENYTOIN SODIUM — Original Application (West-Ward Pharmaceuticals Corp)
FDA approved the original application for fosphenytoin sodium (generic) from West-Ward Pharmaceuticals Corp, authorizing its use as an antic…