Epilepsy
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CLINICAL_TRIALS trial_result · 2013-05-21Clinical Trial Update: Observational Retrospective Study of Effectivity and Tolerability in Patients With Lacosamide Medication
This clinical trial update reports an observational retrospective study assessing the effectiveness and tolerability of lacosamide in patien…
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CLINICAL_TRIALS trial_result · 2013-05-14Clinical Trial Update: Evaluating the Transporter Protein Inhibitor Probenecid In Patients With Epilepsy [Phase 4]
Phase 4 trial evaluating probenecid in epilepsy was terminated; results were posted on May 14, 2013.
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CLINICAL_TRIALS trial_result · 2013-05-13Clinical Trial Update: ZAGAL Study: Evaluating Effectiveness and Tolerability of Zonisamide as Adjunctive Therapy in Patients With Partial Onset Seizures Treated With Two Antiepileptic Drugs [Phase 4]
This update reports the completion of the Phase 4 ZAGAL trial evaluating zonisamide as adjunctive therapy for partial-onset seizures in pati…
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CLINICAL_TRIALS trial_result · 2013-05-09Clinical Trial Update: Epilepsy Motion Sensing
This entry indicates the completion of a clinical trial evaluating epilepsy motion sensing technology sponsored by MedtronicNeuro.
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FDA approval · 2013-04-26FDA Approved: OXCARBAZEPINE — Supplemental Application (Advagen Pharma Limited)
FDA approved a supplemental application for Oxcarbazepine by Advagen Pharma Limited under ANDA 077747.
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CLINICAL_TRIALS safety_alert · 2013-04-22Clinical Trial Update: Post-Authorization Safety Study to Assess the Safety of Vimpat as add-on Therapy in Patients With Partial-onset Seizures
Post-authorization safety study update assessing the safety of Vimpat (lacosamide) as add-on therapy in patients with partial-onset seizures…
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CLINICAL_TRIALS trial_result · 2013-04-15Clinical Trial Update: A Simulation-based Intervention for Caregivers of Children With Seizures [NA]
Clinical trial from the University of Calgary completed a simulation-based intervention for caregivers of children with epilepsy/seizures. T…
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FDA approval · 2013-04-09FDA Approved: GABAPENTIN — Supplemental Application (Advagen Pharma Ltd)
FDA approved a supplemental application for gabapentin submitted by Advagen Pharma Ltd.
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CLINICAL_TRIALS withdrawal · 2013-04-04Clinical Trial Update: GW273225 Therapy Added To Current Seizure Treatments In Patients With Partial Seizures [Phase 2]
A Phase 2 trial evaluating GW273225 as add-on therapy for partial seizures in epilepsy was withdrawn.
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CLINICAL_TRIALS trial_result · 2013-03-07Clinical Trial Update: An Open Label Study of L059 Intravenous (IV) in Japanese Epilepsy Subjects With Partial Onset Seizures [Phase 2]
An open-label Phase 2 study evaluating intravenous L059 in Japanese patients with epilepsy and partial onset seizures completed, with result…
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FDA label_change · 2013-03-06FDA Approved: TEGRETOL — Supplemental Application (Novartis Pharmaceuticals Corporation)
The FDA approved a supplemental application for Tegretol (carbamazepine) filed by Novartis Pharmaceuticals Corporation. The supplemental act…
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FDA approval · 2013-03-06FDA Approved: TEGRETOL — Supplemental Application (Novartis Pharmaceuticals Corporation)
FDA approved a supplemental application for Tegretol (carbamazepine) submitted by Novartis Pharmaceuticals Corporation.
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FDA approval · 2013-03-06FDA Approved: DILANTIN-125 — Supplemental Application (Viatris Specialty LLC)
FDA approved a supplemental application for DILANTIN-125 (phenytoin) from Viatris Specialty LLC. This action adds the 125 mg strength to the…
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CLINICAL_TRIALS trial_result · 2013-03-06Clinical Trial Update: Standardized Educational Plan for Epilepsy Patients With Comorbidities [Phase 4]
A Phase 4 clinical trial update reports completion of a study evaluating a standardized educational plan for epilepsy patients with comorbid…
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CLINICAL_TRIALS trial_result · 2013-03-01Clinical Trial Update: ESOXC-ER Efficacy and Safety of an Extended Release (ER) Formulation of Oxcarbazepine (Apydan Extent) in Epileptic Patients
A completed clinical trial evaluating the efficacy and safety of an extended-release formulation of oxcarbazepine (Apydan Extent) in patient…
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FDA approval · 2013-02-28FDA Approved: LEVETIRACETAM — Supplemental Application (BluePoint Laboratories)
FDA approved a supplemental application for levetiracetam from BluePoint Laboratories under ANDA 078993. This approval relates to the generi…
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FDA approval · 2013-02-28FDA Approved: LEVETIRACETAM — Supplemental Application (Cranbury Pharmaceuticals, LLC)
FDA approved a supplemental application for levetiracetam submitted by Cranbury Pharmaceuticals, LLC.
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FDA approval · 2013-02-28FDA Approved: LEVETIRACETAM — Original Application (Camber Pharmaceuticals, Inc.)
FDA approved Camber Pharmaceuticals' original ANDA for levetiracetam oral, authorizing a generic version of the antiepileptic drug.
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FDA approval · 2013-02-27FDA Approved: LEVETIRACETAM — Supplemental Application (Aurobindo Pharma Limited)
The FDA approved a supplemental application for a levetiracetam generic produced by Aurobindo Pharma Limited under an ANDA.
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FDA approval · 2013-02-27FDA Approved: DEPAKOTE — Supplemental Application (AbbVie Inc.)
The FDA approved AbbVie's supplemental application for DEPAKOTE (divalproex sodium), updating regulatory labeling as part of the supplementa…
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FDA approval · 2013-02-27FDA Approved: LEVETIRACETAM — Supplemental Application (QUAGEN PHARMACEUTICALS LLC)
FDA approved a supplemental application for levetiracetam by Quagen Pharmaceuticals LLC.
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FDA approval · 2013-02-27FDA Approved: LEVETIRACETAM — Supplemental Application (Patrin Pharma, Inc.)
The FDA approved a supplemental application for levetiracetam (generic) submitted by Patrin Pharma, Inc. under ANDA078582.
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FDA approval · 2013-02-19FDA Approved: TOPIRAMATE — Supplemental Application (Unichem Pharmaceuticals (USA), Inc.)
FDA approved a supplemental application for Topiramate from Unichem Pharmaceuticals (USA), Inc., confirming approval of a supplemental chang…
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FDA approval · 2013-02-08FDA Approved: TRILEPTAL — Supplemental Application (Novartis Pharmaceuticals Corporation)
FDA approved a supplemental application for TRILEPTAL (oxcarbazepine) submitted by Novartis Pharmaceuticals Corporation. The action updates …
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FDA approval · 2013-02-08FDA Approved: TRILEPTAL — Supplemental Application (Novartis Pharmaceuticals Corporation)
The FDA approved a supplemental application for Trileptal (oxcarbazepine) submitted by Novartis Pharmaceuticals Corporation.