Epilepsy
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CLINICAL_TRIALS trial_result · 2013-12-03Clinical Trial Update: Clinical Study of Lamotrigine to Treat Newly Diagnosed Epilepsy [Phase 3]
A Phase 3 clinical trial evaluating lamotrigine for newly diagnosed epilepsy has completed and posted results.
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CLINICAL_TRIALS trial_result · 2013-11-26Clinical Trial Update: Monotherapy With Levetiracetam in Newly Diagnosed Patients Suffering From Epilepsy [Phase 3]
A Phase 3 trial of levetiracetam monotherapy in newly diagnosed patients with generalized epilepsy has completed.
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CLINICAL_TRIALS trial_result · 2013-11-26Clinical Trial Update: Open Label Safety and Efficacy Study of Levetiracetam in Korean Patients With Epilepsy [Phase 3]
Open-label Phase 3 safety and efficacy study of levetiracetam in Korean patients with partial epilepsy has completed.
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CLINICAL_TRIALS trial_result · 2013-11-26Clinical Trial Update: Study on Safety and Efficacy of Levetiracetam in the Adjunctive Treatment of Female Subjects With C1 Catamenial Epilepsy [Phase 4]
Phase 4 clinical trial evaluating the safety and efficacy of adjunctive levetiracetam in female subjects with catamenial epilepsy has been c…
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CLINICAL_TRIALS trial_result · 2013-11-26Clinical Trial Update: Study to Evaluate the Safety and Efficacy of Levetiracetam in Patients Suffering From Idiopathic Generalized Epilepsy With Primary Generalized Tonic-clonic Seizures [Phase 3]
Phase 3 trial evaluating safety and efficacy of levetiracetam in idiopathic generalized epilepsy with primary generalized tonic-clonic seizu…
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CLINICAL_TRIALS trial_result · 2013-11-26Clinical Trial Update: Monotherapy With Levetiracetam or Carbamazepine in Patients Suffering From Epilepsy. [Phase 3]
Phase 3 trial comparing monotherapy with levetiracetam versus carbamazepine in patients with epilepsy has completed.
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FDA approval · 2013-11-21FDA Approved: ONFI — Supplemental Application (Lundbeck Pharmaceuticals LLC)
The FDA approved a supplemental application for ONFI (clobazam) filed by Lundbeck Pharmaceuticals LLC.
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CLINICAL_TRIALS trial_result · 2013-11-15Clinical Trial Update: Pharmacokinetic Study of Levetiracetam in Epileptic Pediatric Subjects Ranging in Age From 1 Month to Less Than 4 Years Old [Phase 2]
Phase 2 pharmacokinetic study of levetiracetam in pediatric epilepsy patients aged 1 month to under 4 years completed.
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CLINICAL_TRIALS trial_result · 2013-11-15Clinical Trial Update: Trial to Evaluate the Safety and Efficacy of Keppra After Conversion to Mono-therapy in Subjects With Partial Epilepsy [Phase 4]
Phase 4 trial evaluating the safety and efficacy of levetiracetam (Keppra) as monotherapy after conversion in subjects with partial epilepsy…
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CLINICAL_TRIALS trial_result · 2013-11-15Clinical Trial Update: S.K.A.T.E.: Safety of Keppra as Adjunctive Therapy in Epilepsy [Phase 4]
A Phase 4 safety study evaluating Keppra (levetiracetam) as adjunctive therapy in epilepsy has completed. The update indicates the trial has…
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CLINICAL_TRIALS trial_result · 2013-11-15Clinical Trial Update: Pharmacovigilance Study of Keppra. SPAIN - SKATE : Safety of Keppra as Adjunctive Therapy in Epilepsy [Phase 4]
This report notes the completion of a Phase 4 pharmacovigilance study (SKATE) evaluating the safety of Keppra (levetiracetam) as adjunctive …
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CLINICAL_TRIALS trial_result · 2013-11-15Clinical Trial Update: A Phase IV-Pharmacovigilance Study of Keppra Greece - S.K.A.T.E.: Safety of Keppra as Adjunctive Therapy in Epilepsy [Phase 4]
Phase IV pharmacovigilance study update evaluating the safety of Keppra as adjunctive therapy in epilepsy (S.K.A.T.E.) conducted in Greece.
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CLINICAL_TRIALS trial_result · 2013-11-11Clinical Trial Update: Developmental Effects On Children Of Women Who Take Antiepileptic Drugs During Pregnancy
Completed clinical trial evaluating developmental outcomes in children born to women taking antiepileptic drugs during pregnancy, with a foc…
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CLINICAL_TRIALS trial_result · 2013-11-11Clinical Trial Update: Study of Retigabine Immediate Release as Adjunctive Therapy to Specified Monotherapy Antiepileptic Treatments in Adults With Partial-Onset Seizures [Phase 3]
Phase 3 trial evaluating retigabine immediate release as adjunctive therapy for partial-onset seizures in adults has completed, with results…
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FDA approval · 2013-11-08FDA Approved: APTIOM — Original Application (Sumitomo Pharma America, Inc.)
FDA approved APTIOM (eslicarbazepine acetate) from Sumitomo Pharma America as an original NDA for use in adults with partial-onset seizures …
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FDA approval · 2013-11-08FDA Approved: TEGRETOL — Supplemental Application (Novartis Pharmaceuticals Corporation)
FDA approved a supplemental application for Tegretol (carbamazepine) submitted by Novartis Pharmaceuticals Corporation. The approval updates…
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FDA approval · 2013-11-08FDA Approved: TEGRETOL — Supplemental Application (Novartis Pharmaceuticals Corporation)
FDA approves a supplemental application for Tegretol (carbamazepine) submitted by Novartis Pharmaceuticals Corporation, resulting in an upda…
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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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FDA approval · 2013-10-17FDA Approved: LAMOTRIGINE — Original Application (Actavis Pharma, Inc.)
FDA approved a generic lamotrigine product from Actavis Pharma under an Original Application (ANDA 200672).
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FDA approval · 2013-10-11FDA Approved: ZONEGRAN — Supplemental Application (Advanz Pharma (US) Corp.)
The FDA approved a supplemental application for Zonegran (zonisamide) submitted by Advanz Pharma (US) Corp., updating the labeling for Zoneg…
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FDA approval · 2013-10-11FDA Approved: VIMPAT — Supplemental Application (UCB, Inc.)
FDA has approved a supplemental application for Vimpat (lacosamide) submitted by UCB, Inc., updating the product labeling. This approval upd…
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CLINICAL_TRIALS trial_result · 2013-10-10Clinical Trial Update: Efficacy and Safety of Eslicarbazepine Acetate as Adjunctive Therapy for Refractory Partial Seizures [Phase 3]
A Phase 3 trial evaluating eslicarbazepine acetate as add-on therapy for refractory partial seizures reported efficacy and safety results; t…
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FDA approval · 2013-10-04FDA Approved: LEVETIRACETAM — Supplemental Application (WG Critical Care, LLC)
The FDA approved a supplemental application for levetiracetam submitted by WG Critical Care, LLC.
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FDA approval · 2013-10-02FDA Approved: VIMPAT — Supplemental Application (UCB, Inc.)
The FDA approved a supplemental application for Vimpat (lacosamide) filed by UCB, Inc., resulting in an approved modification to the product…
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FDA approval · 2013-09-25FDA Approved: FOSPHENYTOIN SODIUM — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approved a supplemental application for fosphenytoin sodium by Hikma Pharmaceuticals USA Inc., approving changes to the approved product…