Epilepsy

• FDA approval · 2011-09-29
  FDA Approved: LAMOTRIGINE — Supplemental Application (Dr.Reddy's Laboratories Limited)

  FDA approved a supplemental application for Lamotrigine by Dr. Reddy's Laboratories Limited (ANDA076708), indicating a change related to the…

• FDA approval · 2011-09-29
  FDA Approved: LAMOTRIGINE — Supplemental Application (Dr.Reddy's Laboratories Limited)

  FDA approved a supplemental application for Lamotrigine from Dr. Reddy's Laboratories Limited.

• FDA approval · 2011-09-27
  FDA Approved: CARBAMAZEPINE — Supplemental Application (Torrent Pharmaceuticals Limited)

  FDA approves a supplemental application for Carbamazepine from Torrent Pharmaceuticals Limited.

• FDA approval · 2011-09-27
  FDA Approved: ZONISAMIDE — Supplemental Application (Viona Pharmaceuticals Inc)

  FDA approved a supplemental application for zonisamide submitted by Viona Pharmaceuticals, indicating approval of changes to the product.

• FDA approval · 2011-09-23
  FDA Approved: ZONEGRAN — Supplemental Application (Advanz Pharma (US) Corp.)

  FDA records an approval supplement for Zonegran (zonisamide) submitted by Advanz Pharma (US) Corp.

• Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
• FDA approval · 2011-09-20
  FDA Approved: LEVETIRACETAM — Supplemental Application (Dr. Reddy's Laboratories Limited)

  The FDA approved a supplemental application for levetiracetam submitted by Dr. Reddy's Laboratories Limited.

• FDA approval · 2011-09-20
  FDA Approved: PRIMIDONE — Supplemental Application (Dr. Reddy's Laboratories Limited)

  FDA approved a supplemental application for Primidone submitted by Dr. Reddy's Laboratories Limited. This action concerns a generic version …

• FDA approval · 2011-09-15
  FDA Approved: LEVETIRACETAM — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  FDA approves a supplemental application for LEVETIRACETAM from Lupin Pharmaceuticals, Inc. This is a supplemental approval for the generic p…

• FDA approval · 2011-09-13
  FDA Approved: FELBAMATE — Original Application (Amneal Pharmaceuticals of New York LLC)

  FDA approved the original ANDA for felbamate from Amneal Pharmaceuticals of New York LLC.

• FDA approval · 2011-09-12
  FDA Approved: LEVETIRACETAM — Original Application (Apotex Corp.)

  FDA approves the original application for a generic levetiracetam (Apotex Corp.), enabling a generic version of the anticonvulsant for seizu…

• FDA approval · 2011-09-12
  FDA Approved: LEVETIRACETAM — Original Application (Lupin Pharmaceuticals, Inc.)

  FDA approved Lupin Pharmaceuticals' generic version of levetiracetam through an Original Application (ANDA), adding a generic option for thi…

• FDA approval · 2011-08-30
  FDA Approved: OXCARBAZEPINE — Supplemental Application (Breckenridge Pharmaceutical, Inc.)

  The FDA approved a supplemental application for oxcarbazepine from Breckenridge Pharmaceutical, Inc.

• FDA approval · 2011-08-30
  FDA Approved: GABAPENTIN — Supplemental Application (Zydus Pharmaceuticals USA Inc.)

  The FDA approved a supplemental application for gabapentin submitted by Zydus Pharmaceuticals USA Inc.

• FDA approval · 2011-08-30
  FDA Approved: GABAPENTIN — Supplemental Application (Aurobindo Pharma Limited)

  The FDA approved a supplemental application for Gabapentin from Aurobindo Pharma Limited under an approved ANDA.

• FDA approval · 2011-08-29
  FDA Approved: GABAPENTIN — Supplemental Application (Exelan Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for Gabapentin from Exelan Pharmaceuticals, Inc. (ANDA 090705).

• FDA approval · 2011-08-29
  FDA Approved: GABAPENTIN — Supplemental Application (BluePoint Laboratories)

  FDA approves a supplemental application for Gabapentin from BluePoint Laboratories, updating the existing approval for the generic product.

• FDA approval · 2011-08-22
  FDA Approved: CARBATROL — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

  The FDA approved a supplemental application for CARBATROL (carbamazepine) filed by Takeda Pharmaceuticals America, Inc.

• FDA approval · 2011-08-10
  FDA Approved: KEPPRA — Supplemental Application (UCB, Inc.)

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

• FDA approval · 2011-08-10
  FDA Approved: KEPPRA XR — Supplemental Application (UCB, Inc.)

  The FDA approved a supplemental application for KEPPRA XR, approving an extended-release formulation of levetiracetam manufactured by UCB, I…

• FDA approval · 2011-08-10
  FDA Approved: VIMPAT — Supplemental Application (UCB, Inc.)

  The FDA approved a supplemental application for VIMPAT (lacosamide) from UCB, Inc., updating the labeling and/or indications for this antiep…

• FDA approval · 2011-08-05
  FDA Approved: LEVETIRACETAM — Original Application (Aryeh Pharma corp)

  FDA approved Aryeh Pharma's generic version of levetiracetam under an original application (ANDA 091485). It is used to treat seizures in pe…

• FDA approval · 2011-08-04
  FDA Approved: LAMICTAL ODT — Supplemental Application (GlaxoSmithKline LLC)

  FDA approved a supplemental application for LAMICTAL ODT (lamotrigine) submitted by GlaxoSmithKline LLC. The action updates the product's ap…

• FDA approval · 2011-08-04
  FDA Approved: LAMICTAL XR — Supplemental Application (GlaxoSmithKline LLC)

  FDA approved a supplemental application for LAMICTAL XR (lamotrigine) from GlaxoSmithKline LLC, authorizing changes to the product labeling.

• FDA approval · 2011-07-21
  FDA Approved: GABAPENTIN — Original Application (TIME CAP LABORATORIES, INC)

  FDA approved gabapentin as a generic drug under an Original Application submitted by Time Cap Laboratories, Inc. This approval enables marke…

• FDA approval · 2011-07-14
  FDA Approved: GABAPENTIN — Supplemental Application (Ascend Laboratories, LLC)

  FDA approved a supplemental application for gabapentin submitted by Ascend Laboratories, LLC.