Epilepsy
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Sign up freeTop drugs studied for this disease
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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 · 2021-03-16FDA 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 · 2021-03-10FDA Approved: LAMOTRIGINE — Supplemental Application (Zydus Pharmaceuticals USA Inc.)
The FDA approved a supplemental application for Lamotrigine from Zydus Pharmaceuticals USA Inc., indicating an update to its labeling/indica…
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FDA approval · 2021-03-05FDA Approved: GABAPENTIN — Supplemental Application (Granules Pharmaceuticals Inc)
FDA approved Granules Pharmaceuticals Inc's supplemental application for gabapentin granules, approving a new granulated formulation of a ge…
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CLINICAL_TRIALS trial_result · 2021-03-04Clinical Trial Update: Use of Clobazam for Epilepsy and Anxiety [Phase 4]
Phase 4 trial update on the use of clobazam for epilepsy and anxiety has completed with posted results.
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FDA approval · 2021-02-23FDA Approved: FYCOMPA — Supplemental Application (Eisai Inc.)
The FDA approved a supplemental application for FYCOMPA (perampanel) submitted by Eisai Inc.
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FDA approval · 2021-02-22FDA Approved: ACETAZOLAMIDE — Original Application (TRUPHARMA, LLC)
The FDA approved an original ANDA for Acetazolamide, a generic version manufactured by TRUPHARMA, 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 · 2021-02-17FDA Approved: FOSPHENYTOIN SODIUM — Supplemental Application (Amneal Pharmaceuticals LLC)
The FDA approved a supplemental application for fosphenytoin sodium submitted by Amneal Pharmaceuticals LLC, signaling an updated approval f…
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FDA approval · 2021-02-16FDA Approved: PHENYTOIN SODIUM — Supplemental Application (Acella Pharmaceuticals, LLC)
The FDA has approved Acella Pharmaceuticals' supplemental application for phenytoin sodium. This action pertains to their generic anti-seizu…
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FDA approval · 2021-02-16FDA Approved: DILANTIN-125 — Supplemental Application (Viatris Specialty LLC)
The FDA approved a supplemental application for DILANTIN-125 (PHENYTOIN) by Viatris Specialty LLC.
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FDA approval · 2021-02-16FDA Approved: PHENYTOIN SODIUM — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approved a supplemental application for Phenytoin Sodium from Hikma Pharmaceuticals USA Inc.
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FDA approval · 2021-02-10FDA Approved: DEPAKOTE — Supplemental Application (AbbVie Inc.)
FDA approved a supplemental NDA for Depakote (divalproex sodium) submitted by AbbVie Inc.
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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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CLINICAL_TRIALS trial_result · 2021-02-08Clinical Trial Update: Effects of Clobazam on Sleep and Daytime Function in Patients With Epilepsy
Clinical trial update assessing how clobazam affects sleep and daytime function in epilepsy patients; results posted after completion.
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FDA approval · 2021-02-05FDA Approved: DIAZEPAM INTENSOL — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
The FDA approved a supplemental application for Diazepam Intensol from Hikma Pharmaceuticals USA Inc.
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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: NAYZILAM — Supplemental Application (UCB, Inc.)
FDA approved a supplemental application for Nayzilam (midazolam) by UCB, expanding its approved use/labeling. This action formalizes updated…
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FDA approval · 2021-02-05FDA Approved: VALTOCO — Supplemental Application (Neurelis, Inc)
The FDA approved a supplemental application for VALTOCO (diazepam) submitted by Neurelis, Inc.
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FDA approval · 2021-02-05FDA Approved: CLONAZEPAM — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
FDA approved a supplemental application for clonazepam from Teva Pharmaceuticals USA, Inc., to modify labeling.
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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 label_change · 2021-02-05FDA Approved: ATIVAN — Supplemental Application (Bausch Health US LLC)
The FDA approved a supplemental application for ATIVAN (lorazepam) submitted by Bausch Health US LLC, resulting in a labeling change for the…
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FDA label_change · 2021-02-05FDA Approved: KLONOPIN — Supplemental Application (H2-Pharma, LLC)
The FDA approved a supplemental application for KLONOPIN (clonazepam) from H2-Pharma, LLC, resulting in changes to the product labeling.
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CLINICAL_TRIALS trial_result · 2021-02-03Clinical Trial Update: Inpatient, Dose-Ranging Study of Staccato Alprazolam in Epilepsy With Predictable Seizure Pattern [Phase 2]
Phase 2 trial update for Staccato alprazolam in epilepsy with predictable seizures has completed with posted results.
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FDA approval · 2021-01-29FDA Approved: VIGABATRIN — Original Application (Dr. Reddys Laboratories Inc.,)
FDA approves Dr. Reddy's Laboratories' original ANDA for vigabatrin, the generic form of this anticonvulsant.