Lennox-gastaut Syndrome
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Sign up freeTop drugs studied for this disease
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FDA approval · 2021-05-11FDA Approved: RUFINAMIDE — Original Application (Camber Pharmaceuticals, Inc.)
FDA approved Camber Pharmaceuticals' generic Rufinamide (ANDA 204993) for the treatment of seizures associated with Lennox-Gastaut syndrome,…
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FDA approval · 2021-03-16FDA Approved: SYMPAZAN — Supplemental Application (Aquestive Therapeutics)
FDA approved a supplemental application for Sympazan (clobazam) by Aquestive Therapeutics. The action updates the product labeling (and rela…
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FDA approval · 2021-02-23FDA Approved: RUFINAMIDE — Original Application (Ascend Laboratories, LLC)
FDA approved Rufinamide under an original ANDA from Ascend Laboratories, LLC.
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CLINICAL_TRIALS trial_result · 2021-02-18Clinical Trial Update: A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of TAK-935 (OV935) as an Adjunctive Therapy in Pediatric Participants With Developmental and/or Epileptic Encephalopathies [Phase 2]
Phase 2 trial in pediatric epilepsy evaluating TAK-935 as adjunctive therapy; completed with posted results.
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FDA approval · 2021-02-05FDA Approved: ONFI — Supplemental Application (Lundbeck Pharmaceuticals LLC)
The FDA approved a supplemental application for ONFI (clobazam) from Lundbeck Pharmaceuticals LLC, expanding its approved use for seizures i…
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FDA approval · 2021-02-05FDA Approved: SYMPAZAN — Supplemental Application (Aquestive Therapeutics)
FDA approved a supplemental application for Sympazan (clobazam) from Aquestive Therapeutics.
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FDA approval · 2021-02-05FDA Approved: ONFI — Supplemental Application (Lundbeck Pharmaceuticals LLC)
FDA approved a supplemental application for ONFI (clobazam) submitted by Lundbeck Pharmaceuticals LLC. The action represents an approval of …
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FDA approval · 2020-12-18FDA Approved: RUFINAMIDE — Original Application (Lupin Pharmaceuticals, Inc.)
FDA approved Lupin Pharmaceuticals' generic Rufinamide via an ANDA for seizures associated with Lennox-Gastaut syndrome.
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FDA label_change · 2020-12-09FDA Approved: SYMPAZAN — Supplemental Application (Aquestive Therapeutics)
FDA approved a supplemental application for Sympazan (clobazam) from Aquestive Therapeutics, resulting in changes to the drug’s labeling/ind…
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CLINICAL_TRIALS trial_result · 2020-11-02Clinical Trial Update: Research on Cognitive Effect of Cannabidiol on Dravet Syndrome and Lennox-Gastaut SyndromeGastaut Syndrome [Phase 3]
Phase 3 trial update investigating the cognitive effects of cannabidiol in Dravet Syndrome and Lennox-Gastaut Syndrome.
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FDA approval · 2020-10-22FDA Approved: EPIDIOLEX — Supplemental Application (Jazz Pharmaceuticals, Inc.)
FDA approved a supplemental application for Epidiolex (cannabidiol) from Jazz Pharmaceuticals.
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FDA approval · 2020-08-11FDA Approved: RUFINAMIDE — Supplemental Application (Bionpharma Inc.)
FDA approves a supplemental application for Rufinamide from Bionpharma Inc., updating the approved product under a supplemental submission.
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FDA approval · 2020-08-07FDA Approved: RUFINAMIDE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approved a supplemental application for Rufinamide from Hikma Pharmaceuticals USA Inc., updating the labeling for the product.
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FDA approval · 2020-07-31FDA Approved: EPIDIOLEX — Supplemental Application (Jazz Pharmaceuticals, Inc.)
FDA approves a supplemental application for Epidiolex (cannabidiol) from Jazz Pharmaceuticals, expanding its labeling to reflect additional …
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FDA approval · 2020-04-16FDA Approved: RUFINAMIDE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
The FDA approved a supplemental application for Rufinamide (Hikma Pharmaceuticals USA Inc.) under ANDA204988, signaling an approved addition…
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FDA approval · 2020-02-24FDA Approved: CLOBAZAM — Original Application (NorthStar RxLLC)
The FDA approved CLOBAZAM (clobazam) from NorthStar RxLLC through an original abbreviated new drug application. This marks the entry of a ge…
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FDA approval · 2019-11-28FDA Approved: BANZEL — Supplemental Application (Eisai Inc.)
FDA approves a supplemental application for BANZEL (rufinamide) from Eisai Inc.
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FDA approval · 2019-11-28FDA Approved: BANZEL — Supplemental Application (Eisai Inc.)
FDA approved a supplemental application for BANZEL (rufinamide) submitted by Eisai Inc. for use in Lennox-Gastaut syndrome.
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FDA approval · 2019-09-06FDA Approved: CLOBAZAM — Original Application (Ascend Laboratories, LLC)
FDA approved Ascend Laboratories' CLOBAZAM (clobazam) as an original generic application, authorizing a generic version of the drug. The app…
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CLINICAL_TRIALS trial_result · 2019-08-06Clinical Trial Update: Study of Rufinamide in Pediatric Subjects 1 to Less Than 4 Years of Age With Lennox-Gastaut Syndrome Inadequately Controlled With Other Anti-epileptic Drugs [Phase 3]
Phase 3 clinical trial of Rufinamide in children aged 1 to <4 years with Lennox-Gastaut Syndrome; study completed with results posted in 201…
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FDA approval · 2019-05-31FDA Approved: FELBAMATE — Original Application (Novitium Pharma LLC)
FDA approved an Original Application for felbamate by Novitium Pharma LLC, enabling a generic felbamate product for seizure disorders. The p…
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FDA approval · 2019-05-22FDA Approved: EPIDIOLEX — Supplemental Application (Jazz Pharmaceuticals, Inc.)
The FDA approved a supplemental application for Epidiolex (cannabidiol) from Jazz Pharmaceuticals, updating the labeling to reflect the new …
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FDA approval · 2019-04-23FDA Approved: RUFINAMIDE — Original Application (Hikma Pharmaceuticals USA Inc.)
FDA approval of a generic Rufinamide (ANDA 207363) for seizures associated with Lennox-Gastaut syndrome, enabling generic access.
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FDA approval · 2019-04-23FDA Approved: RUFINAMIDE — Original Application (Bionpharma Inc.)
The FDA approved an original application for a generic version of Rufinamide by Bionpharma Inc. for use in treating seizures associated with…
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FDA approval · 2019-04-15FDA Approved: CLOBAZAM — Original Application (Taro Pharmaceuticals U.S.A., Inc.)
FDA approves CLOBAZAM as an original ANDA for a generic clobazam product from Taro Pharmaceuticals U.S.A., Inc.