Epilepsy

• FDA approval · 2006-08-22
  FDA Approved: VALPROIC ACID — Supplemental Application (ANI Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for valproic acid from ANI Pharmaceuticals, indicating an approved change related to its product…

• FDA approval · 2006-08-18
  FDA Approved: GABAPENTIN — Original Application (BluePoint Laboratories)

  The FDA approved BluePoint Laboratories' original application for gabapentin (generic). The approval covers its use as a generic option for …

• FDA approval · 2006-08-16
  FDA Approved: KEPPRA — Supplemental Application (UCB, Inc.)

  FDA approved a supplemental application for Keppra (levetiracetam) submitted by UCB, Inc. The approval updates the drug's labeling per the s…

• FDA approval · 2006-08-15
  FDA Approved: KEPPRA — Supplemental Application (UCB, Inc.)

  FDA approved a supplemental application for Keppra (levetiracetam) submitted by UCB, Inc.

• FDA approval · 2006-08-15
  FDA Approved: KEPPRA — Supplemental Application (UCB, Inc.)

  The FDA approved a supplemental application for Keppra (levetiracetam) from UCB, Inc., updating the drug's labeling as requested in the subm…

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• FDA approval · 2006-07-31
  FDA Approved: KEPPRA — Original Application (UCB, Inc.)

  FDA approved Keppra (levetiracetam) through its original NDA submitted by UCB, Inc., marking the initial approval of the drug for epilepsy.

• FDA approval · 2006-06-28
  FDA Approved: CLONAZEPAM — Original Application (Solco Healthcare LLC)

  FDA approved the original application for a clonazepam generic manufactured by Solco Healthcare LLC.

• FDA approval · 2006-05-31
  FDA Approved: ZONISAMIDE — Original Application (Exelan Pharmaceuticals, Inc.)

  The FDA approved Exelan Pharmaceuticals' original (ANDA) application for zonisamide, enabling a generic version of the anticonvulsant for us…

• CLINICAL_TRIALS trial_result · 2006-05-15
  Clinical Trial Update: Hormone Replacement in Menopausal Women With Epilepsy [Phase 2]

  Phase 2 study evaluating hormone replacement therapy in menopausal women with epilepsy has completed.

• FDA approval · 2006-05-03
  FDA Approved: NEURONTIN — Supplemental Application (Parke-Davis Div of Pfizer Inc)

  FDA approved a supplemental application for Neurontin (gabapentin) submitted by Parke-Davis Div of Pfizer Inc.

• FDA approval · 2006-05-03
  FDA Approved: NEURONTIN — Supplemental Application (Parke-Davis Div of Pfizer Inc)

  The FDA approved a supplemental application for Neurontin (gabapentin) from Parke-Davis Div of Pfizer Inc, resulting in updated labeling.

• FDA approval ·
  FDA Approved: TRILEPTAL — Supplemental Application (Novartis Pharmaceuticals Corporation)

  The FDA approved a supplemental application for TRILEPTAL (oxcarbazepine) filed by Novartis Pharmaceuticals Corporation.