Partial Seizures
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CLINICAL_TRIALS trial_result · 2013-02-06Clinical Trial Update: A Study to Assess the Efficacy and Safety of Adjunctive Zonisamide in Paediatric Partial Onset Seizures (CATZ Extension Study) [Phase 3]
A Phase 3 extension study evaluating adjunctive zonisamide for pediatric partial-onset seizures has completed, with results posted in 2013.
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CLINICAL_TRIALS trial_result · 2013-02-05Clinical Trial Update: Evaluating the Efficacy and Safety of E2007 (Perampanel) Given as Adjunctive Therapy in Subjects With Refractory Partial Seizures [Phase 3]
Phase 3 trial evaluating adjunctive E2007 (perampanel) for refractory partial seizures has completed with results posted.
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CLINICAL_TRIALS trial_result · 2013-02-05Clinical Trial Update: Rufinamide Given as Adjunctive Therapy in Participants With Refractory Partial Seizures [Phase 3]
Phase 3 clinical trial update on Rufinamide as adjunctive therapy for refractory partial seizures in epilepsy patients.
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CLINICAL_TRIALS trial_result · 2013-01-15Clinical Trial Update: Assessing The Long-Term Safety And To Explore The Long-Term Efficacy Of Zonisamide As Monotherapy In Newly Diagnosed Partial Seizures [Phase 3]
Phase 3 trial assessing long-term safety and efficacy of zonisamide as monotherapy for newly diagnosed partial seizures; results posted.
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FDA approval · 2012-12-11FDA Approved: SABRIL — Supplemental Application (Lundbeck Pharmaceuticals LLC)
The FDA approved Lundbeck's supplemental application for SABRIL (vigabatrin), updating the labeling per NDA020427. This approval reflects ch…
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CLINICAL_TRIALS trial_result · 2012-11-22Clinical Trial Update: Evaluating Efficacy and Safety of E2007 (Perampanel) Given as Adjunctive Therapy in Subjects With Refractory Partial Seizures [Phase 3]
Phase 3 trial evaluating the efficacy and safety of Perampanel (E2007) as adjunctive therapy for patients with refractory partial seizures; …
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CLINICAL_TRIALS trial_result · 2012-06-19Clinical Trial Update: An Open Label Study of Levetiracetam in Japanese Pediatric Patients With Partial Seizures [Phase 3]
This open-label Phase 3 trial evaluated levetiracetam in Japanese pediatric patients with partial seizures. Results were posted in 2012 afte…
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FDA approval · 2012-04-26FDA Approved: LEVETIRACETAM — Supplemental Application (Dr. Reddy's Laboratories Limited)
FDA approved a supplemental application for Levetiracetam by Dr. Reddy's Laboratories Limited under the ANDA, reflecting an approved additio…
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FDA approval · 2011-11-04FDA Approved: TIAGABINE HYDROCHLORIDE — Original Application (Sun Pharmaceutical Industries, Inc.)
The FDA approved Sun Pharmaceutical Industries, Inc. tiagabine hydrochloride tablets as an original generic approval for adjunctive treatmen…
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FDA approval · 2011-09-13FDA Approved: FELBAMATE — Original Application (Amneal Pharmaceuticals of New York LLC)
FDA approved the original ANDA for felbamate from Amneal Pharmaceuticals of New York LLC.
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CLINICAL_TRIALS trial_result · 2011-09-02Clinical Trial Update: To Determine Tolerability and Efficacy of Long-term Oral Lacosamide in Patients With Partial Seizures [Phase 2]
A Phase 2 study evaluated the tolerability and efficacy of long-term oral lacosamide in patients with partial seizures; results were posted …
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FDA approval · 2011-08-30FDA Approved: OXCARBAZEPINE — Supplemental Application (Breckenridge Pharmaceutical, Inc.)
The FDA approved a supplemental application for oxcarbazepine from Breckenridge Pharmaceutical, Inc.
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FDA approval · 2011-07-06FDA Approved: FELBAMATE — Supplemental Application (Mylan Pharmaceuticals Inc.)
The FDA approved a supplemental application for Felbamate submitted by Mylan Pharmaceuticals Inc., updating the approved use of Felbamate un…
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CLINICAL_TRIALS trial_result · 2011-06-10Clinical Trial Update: A Study to Evaluate the Dosing, Effectiveness and Safety of Topiramate for the Treatment of Epilepsy [Phase 4]
A Phase 4 clinical trial evaluating dosing, effectiveness, and safety of topiramate for epilepsy.
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CLINICAL_TRIALS trial_result · 2011-06-08Clinical Trial Update: A Study of the Efficacy and Safety of Topiramate in the Treatment of Patients With Epilepsy. [Phase 2]
Phase 2 clinical trial assessing the efficacy and safety of Topiramate in patients with epilepsy, including partial seizures; the study has …
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FDA approval · 2011-05-27FDA Approved: ZONEGRAN — Supplemental Application (Advanz Pharma (US) Corp.)
FDA approved a supplemental application for ZONEGRAN (zonisamide) submitted by Advanz Pharma (US) Corp. under NDA 020789.
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CLINICAL_TRIALS trial_result · 2010-11-22Clinical Trial Update: Determine Safety and Efficacy of Long-term Oral Lacosamide in Patients With Partial Seizures [Phase 3]
Phase 3 study evaluating the safety and efficacy of long-term oral lacosamide in patients with partial seizures; results posted November 22,…
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FDA approval · 2010-09-29FDA Approved: ZONISAMIDE — Supplemental Application (Aurobindo Pharma Limited)
The FDA approved a supplemental application for zonisamide submitted by Aurobindo Pharma Limited. It indicates regulatory approval for chang…
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CLINICAL_TRIALS trial_result · 2010-09-09Clinical Trial Update: Pregabalin In Partial Seizures (PREPS): An Open-Label, Multicenter Add On Therapy Trial [Phase 4]
Open-label Phase 4 trial of pregabalin as add-on therapy for partial seizures was terminated; results posted in 2010.
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FDA approval · 2010-02-26FDA Approved: ZONISAMIDE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
FDA approved Sun Pharmaceutical Industries' supplemental application for zonisamide (generic) under ANDA077634. This action approves the sup…
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CLINICAL_TRIALS trial_result · 2009-11-06Clinical Trial Update: To Evaluate the Long-Term Safety and Efficacy of Pregabalin in Patients With Partial Seizures [Phase 3]
A Phase 3 trial evaluating the long-term safety and efficacy of pregabalin in patients with partial seizures has completed.
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FDA approval · 2009-06-26FDA Approved: OXCARBAZEPINE — Original Application (Sun Pharmaceutical Industries, Inc.)
The FDA approved Sun Pharmaceutical Industries' original ANDA for oxcarbazepine, yielding a generic version of this anticonvulsant.
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FDA approval · 2009-04-23FDA Approved: FELBAMATE — Supplemental Application (Mylan Pharmaceuticals Inc.)
The FDA approved a supplemental application for felbamate (Felbatol) filed by Mylan Pharmaceuticals Inc.
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FDA approval · 2009-04-23FDA Approved: TIAGABINE HYDROCHLORIDE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
The FDA approved a supplemental application for tiagabine hydrochloride under NDA No. NDA020646, managed by Teva Pharmaceuticals USA, Inc.
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FDA approval · 2008-04-09FDA Approved: OXCARBAZEPINE — Original Application (Advagen Pharma Limited)
The FDA approved Advagen Pharma Limited's original ANDA for oxcarbazepine, a generic anticonvulsant.