Epilepsy

• FDA approval · 2009-07-09
  FDA Approved: DILANTIN — Supplemental Application (Viatris Specialty LLC)

  FDA approved a supplemental application for Dilantin (extended phenytoin sodium), a formulation of phenytoin used to treat seizures. The sub…

• FDA approval · 2009-06-30
  FDA Approved: LEVETIRACETAM — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for Levetiracetam from Aurobindo Pharma Limited, granting approval for a generic version under the A…

• FDA approval · 2009-06-29
  FDA Approved: LEVETIRACETAM — Supplemental Application (BluePoint Laboratories)

  FDA approved a supplemental application for LEVETIRACETAM (generic) from BluePoint Laboratories.

• FDA approval · 2009-06-26
  FDA 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.

• FDA approval · 2009-05-29
  FDA Approved: LAMICTAL XR — Original Application (GlaxoSmithKline LLC)

  FDA approved Lamictal XR (lamotrigine) in an original application by GlaxoSmithKline LLC, establishing the extended-release formulation for …

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• FDA approval · 2009-05-08
  FDA Approved: LAMICTAL — Supplemental Application (GlaxoSmithKline LLC)

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

• FDA approval · 2009-05-08
  FDA Approved: MYSOLINE — Supplemental Application (Bausch Health US, LLC)

  FDA approved a supplemental application for MYSOLINE (primidone) from Bausch Health US, LLC.

• FDA approval · 2009-05-08
  FDA Approved: LAMICTAL ODT — Original Application (GlaxoSmithKline LLC)

  The FDA approved a new orally disintegrating tablet formulation of lamotrigine (Lamictal ODT). It was approved under GlaxoSmithKline's origi…

• FDA approval · 2009-05-06
  FDA Approved: ZARONTIN — Supplemental Application (Parke-Davis Div of Pfizer Inc)

  FDA approved a supplemental application for Zarontin (ethosuximide) by Parke-Davis Div of Pfizer Inc, under the ANDA process.

• FDA approval · 2009-05-06
  FDA Approved: DILANTIN — Supplemental Application (Viatris Specialty LLC)

  The FDA approved a supplemental application for Dilantin (Extended Phenytoin Sodium) submitted by Viatris Specialty LLC.

• FDA approval · 2009-04-23
  FDA Approved: TEGRETOL — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application for TEGRETOL (carbamazepine) submitted by Novartis Pharmaceuticals Corporation.

• FDA approval · 2009-04-23
  FDA Approved: ZARONTIN — Supplemental Application (Parke-Davis Div of Pfizer Inc)

  FDA approved a supplemental application for Zarontin (ethosuximide) from Parke-Davis (Pfizer). It updates the labeling for the product.

• FDA approval · 2009-04-23
  FDA Approved: DILANTIN-125 — Supplemental Application (Viatris Specialty LLC)

  FDA approved a supplemental application for DILANTIN-125 (phenytoin) from Viatris Specialty LLC, adding a new dosage strength to the product…

• FDA approval · 2009-04-23
  FDA Approved: CELONTIN — Supplemental Application (Parke-Davis Div of Pfizer Inc)

  The FDA approved a supplemental application for Celontin (methsuximide) from Parke-Davis Div of Pfizer Inc, expanding its labeling for epile…

• FDA approval · 2009-04-23
  FDA Approved: KLONOPIN — Supplemental Application (H2-Pharma, LLC)

  FDA approved a supplemental NDA for KLONOPIN (clonazepam) submitted by H2-Pharma, LLC.

• FDA approval · 2009-04-23
  FDA Approved: FELBAMATE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  The FDA approved a supplemental application for felbamate (Felbatol) filed by Mylan Pharmaceuticals Inc.

• FDA approval · 2009-04-23
  FDA Approved: TEGRETOL XR — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application for Tegretol XR (carbamazepine) submitted by Novartis Pharmaceuticals, indicating an approved modifi…

• FDA approval · 2009-04-23
  FDA Approved: KEPPRA XR — Supplemental Application (UCB, Inc.)

  The FDA approved a supplemental application for KEPPRA XR (levetiracetam) by UCB, Inc., related to the extended-release formulation.

• FDA approval · 2009-04-23
  FDA 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.

• FDA approval · 2009-04-21
  FDA Approved: PRIMIDONE — Supplemental Application (Amneal Pharmaceuticals LLC)

  The FDA approved Amneal Pharmaceuticals LLC's supplemental application for Primidone, an anticonvulsant, under the ANDA process.

• FDA approval · 2009-04-03
  FDA Approved: LEVETIRACETAM SOLUTION — Original Application (Chartwell RX, LLC)

  FDA approved a generic levetiracetam solution (LEVETIRACETAM SOLUTION) under an Original Application by Chartwell RX, LLC. The product provi…

• FDA approval · 2009-03-31
  FDA Approved: CARBAMAZEPINE — Original Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved Sun Pharmaceutical Industries' generic carbamazepine via an original ANDA. It is used to treat epilepsy and trigeminal neuralgi…

• FDA approval · 2009-03-27
  FDA Approved: TOPIRAMATE — Original Application (Aurobindo Pharma Limited)

  FDA approved Aurobindo Pharma Limited's Original Application for Topiramate, granting a generic version of the anticonvulsant Topiramate. Th…

• FDA approval · 2009-03-27
  FDA Approved: TOPIRAMATE — Original Application (Cipla USA Inc.)

  FDA approved Cipla USA Inc.'s generic Topiramate through an original ANDA.

• FDA approval · 2009-03-27
  FDA Approved: TOPIRAMATE — Original Application (Glenmark Pharmaceuticals Inc., USA)

  FDA approved Glenmark's original ANDA for topiramate, enabling a generic version of the anticonvulsant and migraine preventive drug.