Epilepsy

• CLINICAL_TRIALS trial_result · 2011-06-08
  Clinical Trial Update: A Study of the Efficacy and Safety of Topiramate as add-on Therapy in the Treatment of Epilepsy Patients With Difficult to Treat, Partial-onset Seizures. [Phase 2]

  This clinical trial update reports the completion of a Phase 2 study evaluating topiramate as add-on therapy for difficult-to-treat partial-…

• CLINICAL_TRIALS trial_result · 2011-06-08
  Clinical Trial Update: A Study of the Efficacy and Safety of Topiramate Treatment in Patients With Epilepsy [Phase 3]

  Phase 3 study assessing the efficacy and safety of Topiramate in patients with epilepsy; the trial completed.

• CLINICAL_TRIALS trial_result · 2011-06-08
  Clinical Trial Update: A Study of the Efficacy and Safety of Topiramate as add-on Therapy in the Treatment of Epilepsy Patients With Difficult to Treat, Partial-onset Seizures. [Phase 2]

  Phase 2 trial evaluating the efficacy and safety of add-on topiramate in patients with difficult-to-treat epilepsy and partial-onset seizure…

• CLINICAL_TRIALS trial_result · 2011-06-08
  Clinical Trial Update: A Study of the Efficacy and Safety of Topiramate in the Treatment of Patients With Difficult to Control Epilepsy [Phase 2]

  The Phase 2 study of Topiramate in patients with difficult-to-control epilepsy has completed, reporting on its efficacy and safety.

• CLINICAL_TRIALS trial_result · 2011-06-08
  Clinical Trial Update: A Phase 1 Bioavailability Study of Topiramate Oral Liquid Formulation Compared to the Marketed Sprinkle Capsule Formulation in Healthy Adults [Phase 1]

  Phase 1 study comparing the oral liquid formulation of topiramate with the marketed sprinkle capsule formulation to assess bioavailability i…

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• CLINICAL_TRIALS trial_result · 2011-06-08
  Clinical Trial Update: A Study of the Effectiveness and Safety of Topiramate Compared With a Standard Therapy in Patients Newly Diagnosed With Epilepsy [Phase 3]

  This document reports the completion of a Phase 3 trial comparing topiramate with standard therapy in patients newly diagnosed with epilepsy…

• CLINICAL_TRIALS trial_result · 2011-06-08
  Clinical Trial Update: A Study on Safety and Efficacy of Two Doses of Topiramate as Monotherapy in the Treatment of Newly Diagnosed or Recurrent Epilepsy [Phase 3]

  Phase 3 study evaluating the safety and efficacy of two doses of topiramate as monotherapy in patients with newly diagnosed or recurrent epi…

• CLINICAL_TRIALS trial_result · 2011-06-08
  Clinical Trial Update: A Study of the Efficacy and Safety of Topiramate in Epilepsy Patients With Primary Generalized Tonic-clonic Seizures [Phase 3]

  This document reports the completion of a Phase 3 trial evaluating the efficacy and safety of Topiramate in epilepsy patients with primary g…

• CLINICAL_TRIALS trial_result · 2011-06-03
  Clinical Trial Update: A Study of the Efficacy and Safety of Topiramate as an add-on Therapy in the Treatment of Epilepsy Patients With Lennox-Gastaut Syndrome [Phase 3]

  Phase 3 trial assessing the efficacy and safety of add-on topiramate in Lennox-Gastaut syndrome; the study status is completed.

• FDA approval · 2011-05-31
  FDA Approved: LAMICTAL ODT — Supplemental Application (GlaxoSmithKline LLC)

  FDA approved a supplemental application for LAMICTAL ODT (lamotrigine) submitted by GlaxoSmithKline LLC.

• FDA approval · 2011-05-27
  FDA 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.

• FDA approval · 2011-05-27
  FDA Approved: DILANTIN-125 — Supplemental Application (Viatris Specialty LLC)

  FDA approved a supplemental application for DILANTIN-125 (phenytoin) from Viatris Specialty LLC.

• CLINICAL_TRIALS trial_result · 2011-05-25
  Clinical Trial Update: Study Evaluating the Pharmacokinetics of Keppra Extended Release (XR) in Children and Adults With Epilepsy [Phase 2]

  Phase 2 pharmacokinetics study of Keppra Extended Release (XR) in children and adults with epilepsy has completed and results were posted in…

• FDA approval · 2011-05-20
  FDA Approved: CARBAMAZEPINE — Original Application (ANI Pharmaceuticals, Inc.)

  FDA approves ANI Pharmaceuticals' original application to market a generic carbamazepine formulation under an ANDA.

• CLINICAL_TRIALS trial_result · 2011-05-03
  Clinical Trial Update: Effects of Treating Obstructive Sleep Apnea in Epilepsy [Phase 2]

  Phase 2 trial evaluating treatment of obstructive sleep apnea in epilepsy has completed and results were posted in 2011.

• CLINICAL_TRIALS trial_result · 2011-04-27
  Clinical Trial Update: A Post-Marketing Clinical Pharmacokinetics Study Of Gabapentin In Japanese Epileptic Subjects With Renal Impairment [Phase 4]

  Phase 4 pharmacokinetics study in Japanese epileptic patients with renal impairment assessing gabapentin post-marketing implications.

• FDA approval · 2011-04-26
  FDA Approved: LYRICA — Supplemental Application (Parke-Davis Div of Pfizer Inc)

  FDA approved a supplemental application for LYRICA (pregabalin) filed by Parke-Davis Div of Pfizer Inc.

• FDA label_change · 2011-04-25
  FDA Approved: ZARONTIN — Supplemental Application (Parke-Davis Div of Pfizer Inc)

  FDA approves a supplemental application for Zarontin (ethosuximide) from Parke-Davis Div of Pfizer to update the product labeling.

• FDA approval · 2011-04-25
  FDA Approved: LAMICTAL XR — Supplemental Application (GlaxoSmithKline LLC)

  The FDA approved a supplemental application for Lamictal XR (lamotrigine) by GlaxoSmithKline LLC.

• FDA approval · 2011-04-08
  FDA Approved: DILANTIN — Supplemental Application (Viatris Specialty LLC)

  The FDA approved a supplemental application for Dilantin (extended phenytoin sodium) filed by Viatris Specialty LLC.

• FDA approval · 2011-04-08
  FDA Approved: PHENYTOIN INFATABS — Supplemental Application (Prasco Laboratories)

  FDA entry documents a supplemental application for Phenytoin Infatabs (phenytoin) from Prasco Laboratories under ANDA 084427.

• FDA approval · 2011-04-08
  FDA Approved: CLONAZEPAM — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for clonazepam filed by Aurobindo Pharma Limited under ANDA075150.

• FDA approval · 2011-04-05
  FDA Approved: DIVALPROEX SODIUM — Original Application (Unichem Pharmaceuticals (USA), Inc.)

  FDA approved the generic divalproex sodium from Unichem Pharmaceuticals (USA), Inc. under ANDA079163.

• FDA approval · 2011-03-30
  FDA Approved: LAMOTRIGINE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for Lamotrigine from Aurobindo Pharma Limited. This approval confirms the availability of the lamotr…

• FDA approval · 2011-03-30
  FDA Approved: GABAPENTIN — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a supplemental application for gabapentin from Sun Pharmaceutical Industries, Inc. (ANDA077242), confirming regulatory approval…