Status Epilepticus
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CLINICAL_TRIALS trial_result · 2023-06-23Clinical Trial Update: Repeated TMS at Low Frequencies to Reduce Seizure Occurrence [NA]
A clinical trial investigating repeated low-frequency TMS to reduce seizure occurrence was terminated; results were posted in 2023.
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FDA approval · 2023-04-25FDA Approved: DIAZEPAM — Supplemental Application (Hospira, Inc.)
FDA approved Hospira's supplemental application for diazepam (generic) under ANDA 071583. This represents a supplemental approval for a gene…
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CLINICAL_TRIALS trial_result · 2023-02-16Clinical Trial Update: SURESTEP: Transcranial Direct Current Stimulation in Super Refractory Status Epilepticus [NA]
Clinical trial update for SURESTEP evaluating transcranial direct current stimulation in super refractory status epilepticus has been termin…
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FDA approval · 2023-02-08FDA Approved: DIAZEPAM — Supplemental Application (Natco Pharma USA LLC)
FDA approves a supplemental application for Diazepam by Natco Pharma USA LLC, approving a supplemental change to the generic diazepam produc…
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FDA approval · 2023-01-17FDA Approved: DIAZEPAM — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
The FDA approved a supplemental application for diazepam submitted by Hikma Pharmaceuticals USA Inc., marking regulatory action to support t…
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FDA approval · 2023-01-17FDA Approved: DIAZEPAM — Supplemental Application (Chartwell RX, LLC)
FDA approved a supplemental application for diazepam oral solution concentrate from Chartwell RX, LLC, adding/confirming approval for this d…
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FDA approval · 2023-01-17FDA Approved: MIDAZOLAM — Supplemental Application (Steriscience Specialties Private Limited)
FDA approved a supplemental application for Midazolam hydrochloride (Midazolam) by Steriscience Specialties Private Limited under an ANDA.
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FDA approval · 2023-01-13FDA Approved: ATIVAN — Supplemental Application (Bausch Health US LLC)
The FDA approved a supplemental application for ATIVAN (lorazepam) submitted by Bausch Health US LLC. The action indicates a label update or…
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FDA approval · 2023-01-13FDA Approved: LOREEV XR — Supplemental Application (Almatica Pharma LLC)
The FDA approved a supplemental application for LOREEV XR (lorazepam) submitted by Almatica Pharma LLC.
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FDA approval · 2023-01-13FDA Approved: VALIUM — Supplemental Application (Roche Laboratories Inc.)
The FDA approved a supplemental application for Valium (diazepam) from Roche Laboratories Inc., updating the existing NDA.
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FDA approval · 2023-01-11FDA Approved: DIAZEPAM — Supplemental Application (Natco Pharma USA LLC)
FDA approved a supplemental application for diazepam (generic) from Natco Pharma USA LLC under ANDA210363.
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CLINICAL_TRIALS trial_result · 2022-12-15Clinical Trial Update: Intravenous Ganaxolone as Adjunctive Therapy to Treat Subjects With Status Epilepticus [Phase 2]
Phase 2 clinical trial evaluating intravenous ganaxolone as adjunctive therapy for status epilepticus (completed; results posted).
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FDA approval · 2022-11-17FDA Approved: SEZABY — Original Application (Sun Pharmaceutical Industries, Inc.)
FDA approved SEZABY (phenobarbital sodium) from Sun Pharmaceutical Industries via an original NDA. It is an anticonvulsant indicated for sei…
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FDA approval · 2022-11-10FDA Approved: DIAZEPAM — Original Application (Fresenius Kabi USA, LLC)
The FDA approved Fresenius Kabi USA, LLC's Original Application for diazepam (generic diazepam). This approval adds a new generic option for…
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CLINICAL_TRIALS trial_result · 2022-09-21Clinical Trial Update: Effectiveness of Combined Levetiracetam and Midazolam in Generalized Convulsive Status Epilepticus in Children [Phase 2]
A Phase 2 clinical trial evaluated the effectiveness of combining levetiracetam and midazolam for generalized convulsive status epilepticus …
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CLINICAL_TRIALS trial_result · 2021-09-14Clinical Trial Update: Study of Midazolam Hydrochloride Oromucosal Solution (MHOS/SHP615) in Pediatric Patients With Status Epilepticus (Convulsive) in the Community Setting [Phase 3]
Phase 3 trial data for Midazolam Hydrochloride Oromucosal Solution (MHOS/SHP615) in pediatric status epilepticus in community settings has b…
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FDA approval · 2021-06-23FDA Approved: DIAZEPAM — Supplemental Application (Natco Pharma USA LLC)
FDA approved Natco Pharma USA LLC's supplemental application for Diazepam (generic).
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CLINICAL_TRIALS withdrawal · 2021-05-21Clinical Trial Update: Efficacy of Ketamine Infusion Compared With Traditional Anti-epileptic Agents in Refractory Status Epilepticus [Phase 2, Phase 3]
Clinical trial investigating ketamine infusion vs traditional anti-epileptic agents in refractory status epilepticus was withdrawn from phas…
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CLINICAL_TRIALS trial_result · 2021-04-02Clinical Trial Update: Comparison of Efficacy of Phenytoin With Levetireacetam for the Management of Children With Status Epilepticus [Phase 4]
Phase 4 trial evaluating and comparing phenytoin versus levetiracetam for managing status epilepticus in children.
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FDA approval · 2021-03-25FDA Approved: DIAZEPAM — Supplemental Application (Oceanside Pharmaceuticals)
FDA supplemental approval for Diazepam under Oceanside Pharmaceuticals is recorded, confirming the approval of a supplemental application fo…
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FDA approval · 2021-02-08FDA Approved: DIAZEPAM — Supplemental Application (Natco Pharma USA LLC)
FDA approved a supplemental application for Diazepam (generic) from Natco Pharma USA LLC under an ANDA. The action confirms approval of the …
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FDA approval · 2021-02-05FDA Approved: DIAZEPAM — Supplemental Application (Hospira, Inc.)
FDA approved a supplemental application for diazepam from Hospira, Inc., under an ANDA, indicating regulatory approval of the requested chan…
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FDA approval · 2021-02-05FDA Approved: DIAZEPAM — Supplemental Application (Meridian Medical Technologies LLC)
The FDA approved a supplemental application for Diazepam submitted by Meridian Medical Technologies LLC.
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FDA approval · 2021-02-05FDA Approved: DIAZEPAM — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approved Hikma Pharmaceuticals USA Inc.'s supplemental application for Diazepam, approving a generic version of the drug.
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CLINICAL_TRIALS trial_result · 2020-10-08Clinical Trial Update: Ketamine in Refractory Convulsive Status Epilepticus [Phase 3]
Phase 3 trial evaluating ketamine for refractory convulsive status epilepticus has been terminated.