Complex Partial Seizures
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Sign up freeTop drugs studied for this disease
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FDA approval · 2020-10-02FDA Approved: VIGABATRIN — Supplemental Application (Dr. Reddys Laboratories Inc.,)
FDA granted a supplemental approval for Vigabatrin by Dr. Reddys Laboratories Inc., initiating a new regulatory action related to the produc…
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FDA label_change · 2020-10-02FDA Approved: VIGABATRIN — Supplemental Application (Par Health USA, LLC)
The FDA approved a supplemental application for Vigabatrin from Par Health USA, LLC, resulting in updated labeling for the product.
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FDA approval · 2020-10-02FDA Approved: VIGADRONE — Supplemental Application (Upsher-Smith Laboratories, LLC)
The FDA approved a supplemental application for Vigadrone (vigabatrin) from Upsher-Smith Laboratories, LLC. This action authorizes changes r…
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FDA approval · 2019-09-12FDA Approved: VIGABATRIN — Supplemental Application (Amneal Pharmaceuticals NY LLC)
FDA approved a supplemental application for Vigabatrin from Amneal Pharmaceuticals NY LLC.
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FDA approval · 2019-09-12FDA Approved: VIGABATRIN — Supplemental Application (Actavis Pharma, Inc.)
FDA approved Actavis Pharma's supplemental application for Vigabatrin, updating the existing approval for the drug.
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FDA approval · 2019-09-12FDA Approved: VIGABATRIN — Supplemental Application (Dr. Reddys Laboratories Inc.,)
FDA approved a supplemental application for Vigabatrin submitted by Dr. Reddy's Laboratories Inc., enabling continued availability of the ge…
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FDA approval · 2019-07-31FDA Approved: SABRIL — Supplemental Application (Lundbeck Pharmaceuticals LLC)
FDA approved a supplemental application for SABRIL (vigabatrin) submitted by Lundbeck Pharmaceuticals LLC.
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FDA label_change · 2019-05-31FDA Approved: SABRIL — Supplemental Application (Lundbeck Pharmaceuticals LLC)
The FDA approved a supplemental application for SABRIL (vigabatrin) submitted by Lundbeck Pharmaceuticals LLC, resulting in a labeling chang…
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FDA approval · 2019-01-14FDA Approved: VIGABATRIN — Original Application (Actavis Pharma, Inc.)
FDA page documents Actavis Pharma's original application for a generic Vigabatrin product, seeking approval to market a generic version.
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FDA approval · 2018-06-21FDA Approved: VIGADRONE — Original Application (Upsher-Smith Laboratories, LLC)
FDA approved the original generic application for Vigabatrin under the brand VIGADRONE by Upsher-Smith Laboratories, expanding access to the…
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CLINICAL_TRIALS trial_result · 2017-07-12Clinical Trial Update: Sabril for Complex Partial Seizures in Adult Tolerability Study (TS) Patients [Phase 4]
A Phase 4 tolerability study of vigabatrin (Sabril) for complex partial seizures was terminated; results were posted in 2017.
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CLINICAL_TRIALS trial_result · 2017-05-11Clinical Trial Update: Remegal Fixed Dose as Adjunctive Therapy in Patients With Partial Seizures [Phase 3]
A Phase 3 trial of Remegal fixed-dose as adjunctive therapy for partial seizures has completed under sponsor Valexfarm.
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FDA approval · 2017-04-27FDA Approved: VIGABATRIN — Original Application (Par Health USA, LLC)
FDA approves Vigabatrin original Abbreviated New Drug Application for Par Health USA, LLC (generic entry).
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CLINICAL_TRIALS trial_result · 2016-08-16Clinical Trial Update: Efficacy and Safety of Diazepam in the Management of Refractory Epilepsy in Selected Patients Who Require Intermittent Medical Intervention for Acute Repetitive Seizures. [Phase 3]
Phase 3 trial evaluating diazepam for management of refractory epilepsy in patients requiring intermittent medical intervention for acute re…
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CLINICAL_TRIALS research · 2016-07-29Clinical Trial Update: Sabril Patient Registry
The Sabril patient registry update relates to vigabatrin use in infantile spasms and refractory complex partial seizures in adults, and the …
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CLINICAL_TRIALS trial_result · 2016-06-07Clinical Trial Update: A Study of the Structure and Function of the Retina in Adult Patients With Refractory Complex Partial Seizures Treated With Vigabatrin (Sabril®) [Phase 4]
Phase 4 trial updating retinal structure and function in adults with refractory complex partial seizures treated with vigabatrin (Sabril); r…
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FDA label_change · 2014-04-03FDA Approved: SABRIL — Supplemental Application (Lundbeck Pharmaceuticals LLC)
FDA approved a supplemental application for Sabril (vigabatrin) submitted by Lundbeck Pharmaceuticals LLC.
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FDA label_change · 2013-10-26FDA Approved: SABRIL — Supplemental Application (Lundbeck Pharmaceuticals LLC)
The FDA approved a supplemental application for SABRIL (vigabatrin) from Lundbeck Pharmaceuticals LLC, addressing changes to the product lab…
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CLINICAL_TRIALS trial_result · 2013-06-18Clinical Trial Update: An Open-Label Extension Study to Evaluate the Safety and Tolerability of RWJ 333369 as Adjunctive Therapy in Patients 16 Years and Older With Partial Onset Seizures. [Phase 3]
An open-label extension study in adults (16 years and older) with partial-onset seizures evaluated the safety and tolerability of RWJ 333369…
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CLINICAL_TRIALS trial_result · 2013-01-24Clinical Trial Update: A Study of the Effectiveness, Safety, and Tolerability of Carisbamate as Add-On Therapy in Patients With Partial Onset Seizures. [Phase 3]
Phase 3 trial updating on the effectiveness, safety, and tolerability of carisbamate as add-on therapy for partial-onset seizures. The study…
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CLINICAL_TRIALS trial_result · 2012-06-20Clinical Trial Update: A Study of the Efficacy and Safety of RWJ-333369 as add-on Therapy in the Treatment of Partial Onset Seizures. [Phase 3]
Phase 3 clinical trial evaluating the efficacy and safety of RWJ-333369 as add-on therapy for partial-onset seizures; the study has complete…
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CLINICAL_TRIALS trial_result · 2012-06-18Clinical Trial Update: A Study of the Efficacy and Safety of RWJ-333369 as add-on Therapy in the Treatment of Partial Onset Seizures. [Phase 3]
Phase 3 study evaluating RWJ-333369 as add-on therapy for partial onset seizures in epilepsy, assessing efficacy and safety. The trial statu…
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FDA approval · 2011-01-18FDA Approved: SABRIL — Supplemental Application (Lundbeck Pharmaceuticals LLC)
FDA approved a supplemental application for Sabril (vigabatrin) submitted by Lundbeck Pharmaceuticals LLC.
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FDA approval · 2009-08-21FDA Approved: SABRIL — Original Application (Lundbeck Pharmaceuticals LLC)
FDA approved Sabril (vigabatrin) from Lundbeck as an original NDA for the treatment of infantile spasms and refractory complex partial seizu…
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CLINICAL_TRIALS trial_result · 2008-03-04Clinical Trial Update: Effect of Vigabatrin on Brain Blood Flow and Glucose Metabolism
Clinical trial update examining how vigabatrin affects brain blood flow and glucose metabolism in epilepsy, including complex partial seizur…