Lennox-gastaut Syndrome
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Sign up freeTop drugs studied for this disease
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FDA approval · 2023-09-11FDA Approved: CLOBAZAM — Supplemental Application (Upsher-Smith Laboratories, LLC)
The FDA approved a supplemental application for CLOBAZAM (clobazam) from Upsher-Smith Laboratories, LLC.
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FDA approval · 2023-06-16FDA Approved: RUFINAMIDE — Original Application (Aurobindo Pharma Limited)
FDA approved Aurobindo Pharma Limited's original ANDA for a generic Rufinamide product, intended for seizures associated with Lennox-Gastaut…
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FDA approval · 2023-05-30FDA Approved: BANZEL — Supplemental Application (Eisai Inc.)
FDA approved a supplemental application for BANZEL (rufinamide) submitted by Eisai Inc.
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FDA approval · 2023-05-22FDA Approved: CLOBAZAM — Supplemental Application (Amneal Pharmaceuticals NY LLC)
FDA approved a supplemental application for CLOBAZAM (clobazam) from Amneal Pharmaceuticals NY LLC, updating the approval of this generic pr…
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FDA approval · 2023-05-15FDA Approved: RUFINAMIDE — Original Application (Micro Labs Limited)
FDA approved Rufinamide as an original ANDA submission from Micro Labs Limited.
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FDA approval · 2023-05-03FDA Approved: TOPAMAX — Supplemental Application (Janssen Pharmaceuticals, Inc.)
FDA approved Janssen's supplemental application for Topamax (topiramate) and updated the product labeling.
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FDA approval · 2023-05-01FDA Approved: CLOBAZAM — Supplemental Application (Camber Pharmaceuticals, Inc.)
The FDA approved a supplemental application for CLOBAZAM (clobazam) submitted by Camber Pharmaceuticals, Inc. This action represents regulat…
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FDA approval · 2023-05-01FDA Approved: CLOBAZAM — Supplemental Application (Bionpharma Inc.)
FDA approved a supplemental application for CLOBAZAM (clobazam) from Bionpharma Inc., under ANDA208819.
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FDA approval · 2023-04-26FDA Approved: CLOBAZAM — Supplemental Application (Aurobindo Pharma Limited)
FDA approves a supplemental application for CLOBAZAM by Aurobindo Pharma Limited, updating the regulatory status of this clobazam product.
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FDA approval · 2023-01-13FDA Approved: ONFI — Supplemental Application (Lundbeck Pharmaceuticals LLC)
The FDA approved a supplemental application for ONFI (clobazam) from Lundbeck Pharmaceuticals LLC.
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FDA approval · 2023-01-13FDA Approved: ONFI — Supplemental Application (Lundbeck Pharmaceuticals LLC)
The FDA approved a supplemental application for ONFI (clobazam) submitted by Lundbeck Pharmaceuticals LLC.
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FDA approval · 2023-01-13FDA Approved: SYMPAZAN — Supplemental Application (Aquestive Therapeutics)
FDA approved a supplemental application for Sympazan (clobazam) submitted by Aquestive Therapeutics.
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FDA approval · 2023-01-03FDA Approved: FINTEPLA — Supplemental Application (UCB, Inc.)
FDA approved a supplemental application for FINTEPLA (fenfluramine) from UCB, Inc., expanding/ updating its labeling for the treatment of se…
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FDA approval · 2022-11-16FDA Approved: RUFINAMIDE — Supplemental Application (Lupin Pharmaceuticals, Inc.)
The FDA approved Lupin Pharmaceuticals' supplemental application for Rufinamide (generic), expanding its regulatory status for the treatment…
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FDA approval · 2022-10-26FDA Approved: RUFINAMIDE — Original Application (Aurobindo Pharma Limited)
FDA approved Aurobindo Pharma Limited's Rufinamide as a generic drug via an Original Application (ANDA 216549).
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CLINICAL_TRIALS trial_result · 2022-09-01Clinical Trial Update: Investigation of Cognitive Outcomes With Cannabidiol Oral Solution [Phase 4]
Phase 4 investigation of cannabidiol oral solution for cognitive outcomes in Lennox-Gastaut Syndrome was withdrawn.
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FDA approval · 2022-08-17FDA Approved: RUFINAMIDE — Original Application (Lupin Pharmaceuticals, Inc.)
The FDA approved Lupin Pharmaceuticals' generic Rufinamide (ANDA204964) for the treatment of seizures associated with Lennox-Gastaut syndrom…
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CLINICAL_TRIALS withdrawal · 2022-07-14Clinical Trial Update: Melatonin Versus Placebo in the Lennox-Gastaut Syndrome: Neurophysiological and Neuropsychological Effects [Phase 4]
Phase 4 trial of melatonin vs placebo in Lennox-Gastaut syndrome was withdrawn.
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FDA approval · 2022-03-24FDA Approved: CLOBAZAM — Original Application (Aurobindo Pharma Limited)
FDA approved an original ANDA for CLOBAZAM (clobazam) by Aurobindo Pharma Limited. It is a generic treatment for seizures associated with Le…
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CLINICAL_TRIALS trial_result · 2022-03-09Clinical Trial Update: Study of Perampanel as Adjunctive Treatment for Inadequately Controlled Seizures Associated With Lennox-Gastaut Syndrome [Phase 3]
Phase 3 study of perampanel as an adjunctive treatment for inadequately controlled seizures in Lennox-Gastaut syndrome was terminated with r…
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CLINICAL_TRIALS trial_result · 2022-02-03Clinical Trial Update: An Open Label Extension Study of Cannabidiol (GWP42003-P) in Children and Adults With Dravet or Lennox-Gastaut Syndromes [Phase 3]
Open-label extension study of cannabidiol (GWP42003-P) in children and adults with Dravet or Lennox-Gastaut syndromes completed; results pos…
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CLINICAL_TRIALS trial_result · 2022-01-03Clinical Trial Update: The Effects of Cannabidiol (CBD) on Electrical and Autonomic Cardiac Function in Children With Severe Epilepsy [Phase 1, Phase 2]
A terminated phase 1/2 clinical trial evaluating the effects of cannabidiol (CBD) on electrical and autonomic cardiac function in children w…
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FDA approval · 2021-12-03FDA Approved: CLOBAZAM — Supplemental Application (Lupin Pharmaceuticals, Inc.)
FDA approved a supplemental application for CLOBAZAM from Lupin Pharmaceuticals, Inc. to support an updated or expanded use of the product.
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FDA approval · 2021-10-20FDA Approved: CLOBAZAM — Supplemental Application (NorthStar RxLLC)
The FDA approved a supplemental application for CLOBAZAM (clobazam) from NorthStar RxLLC under ANDA 209796, confirming its status as a gener…
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FDA approval · 2021-09-30FDA Approved: EPIDIOLEX — Supplemental Application (Jazz Pharmaceuticals, Inc.)
The FDA has approved a supplemental application for Epidiolex (cannabidiol) from Jazz Pharmaceuticals, Inc., indicating an update to its app…