Epilepsy

• FDA approval · 2024-08-26
  FDA Approved: LEVETIRACETAM ER — Supplemental Application (Westminster Pharmaceuticals, LLC)

  The FDA approved Westminster Pharmaceuticals' supplemental application to authorize the levetiracetam extended-release formulation (LEVETIRA…

• FDA approval · 2024-08-14
  FDA Approved: OXTELLAR XR — Supplemental Application (Supernus Pharmaceuticals, Inc.)

  FDA approved a supplemental application for OXTELLAR XR (oxcarbazepine) from Supernus Pharmaceuticals, expanding its approved labeling.

• FDA approval · 2024-08-13
  FDA Approved: CARBAMAZEPINE — Supplemental Application (Northstar Rx LLC)

  FDA approved a supplemental application for carbamazepine from Northstar Rx LLC under ANDA 216594, indicating regulatory approval of changes…

• FDA approval · 2024-07-29
  FDA Approved: CLOBAZAM — Supplemental Application (Amneal Pharmaceuticals NY LLC)

  The FDA approved a supplemental application for CLOBAZAM (clobazam) submitted by Amneal Pharmaceuticals NY LLC.

• FDA approval · 2024-07-18
  FDA Approved: DIAZEPAM — Original Application (Dr. Reddy's Laboratories Inc)

  FDA approves the Diazepam original application for Dr. Reddy's Laboratories Inc, establishing a generic Diazepam product in the U.S. underAN…

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• FDA approval · 2024-07-16
  FDA Approved: TOPIRAMATE — Original Application (Glenmark Pharmaceuticals Inc., USA)

  FDA approves Glenmark's Original Application for Topiramate, a generic anticonvulsant. Topiramate is approved for certain seizure disorders …

• FDA approval · 2024-07-15
  FDA Approved: CLOBAZAM — Supplemental Application (Novadoz Pharmaceuticals LLC)

  The FDA approved a supplemental application for CLOBAZAM filed by Novadoz Pharmaceuticals LLC.

• FDA approval · 2024-07-12
  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 · 2024-07-10
  FDA Approved: CLOBAZAM — Supplemental Application (Taro Pharmaceuticals U.S.A., Inc.)

  FDA approved a supplemental application for CLOBAZAM (clobazam), a generic seizure medication manufactured by Taro Pharmaceuticals U.S.A., I…

• FDA approval · 2024-07-05
  FDA Approved: LEVETIRACETAM — Supplemental Application (Micro Labs Limited)

  FDA approved a supplemental application for Levetiracetam from Micro Labs Limited.

• FDA approval · 2024-07-03
  FDA Approved: LEVETIRACETAM — Supplemental Application (Baxter Healthcare Corporation)

  FDA approved a supplemental application for levetiracetam by Baxter Healthcare Corporation.

• FDA approval · 2024-06-20
  FDA Approved: APTIOM — Supplemental Application (Sumitomo Pharma America, Inc.)

  FDA approves a supplemental application for APTIOM (eslicarbazepine acetate) submitted by Sumitomo Pharma America, Inc.

• FDA approval · 2024-06-13
  FDA Approved: DIVALPROEX SODIUM — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for divalproex sodium from Aurobindo Pharma Limited.

• FDA approval · 2024-06-13
  FDA Approved: LACOSAMIDE — Supplemental Application (Apotex Corp)

  FDA approved Apotex Corp's lacosamide supplemental application under the ANDA process.

• FDA approval · 2024-06-13
  FDA Approved: TOPIRAMATE — Original Application (Ascend Laboratories, LLC)

  The FDA approved Ascend Laboratories' original application for a generic topiramate product.

• FDA approval · 2024-06-10
  FDA Approved: CLOBAZAM — Supplemental Application (Camber Pharmaceuticals, Inc.)

  FDA approves a supplemental application for CLOBAZAM (clobazam) submitted by Camber Pharmaceuticals, Inc. The action updates the regulatory …

• FDA approval · 2024-06-07
  FDA Approved: MOTPOLY XR — Supplemental Application (Aucta Pharmaceuticals, Inc.)

  FDA approved a supplemental application for MOTPOLY XR (lacosamide) from Aucta Pharmaceuticals, Inc.

• FDA approval · 2024-06-05
  FDA Approved: LAMOTRIGINE — Supplemental Application (Yiling Pharmaceutical, Inc.)

  FDA approved Yiling Pharmaceutical's supplemental application to market Lamotrigine Extended-Release, a lamotrigine product.

• FDA approval · 2024-06-04
  FDA Approved: BRIVARACETAM — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for brivaracetam from Aurobindo Pharma Limited. This enables the marketing of a generic brivaracetam…

• FDA approval · 2024-05-29
  FDA Approved: GABAPENTIN — Supplemental Application (Amneal Pharmaceuticals LLC)

  The FDA approved a supplemental application for Gabapentin submitted by Amneal Pharmaceuticals LLC under ANDA202024.

• FDA approval · 2024-05-29
  FDA Approved: LEVETIRACETAM — Supplemental Application (Granules Pharmaceuticals Inc.)

  FDA approved a supplemental application for levetiracetam granules from Granules Pharmaceuticals Inc., adding a new formulation to the produ…

• FDA approval · 2024-05-24
  FDA Approved: CLOBAZAM — Supplemental Application (Bionpharma Inc.)

  The FDA approved a supplemental application for CLOBAZAM filed by Bionpharma Inc., confirming an additional approval for this clobazam produ…

• FDA approval · 2024-05-24
  FDA Approved: LACOSAMIDE — Original Application (Macleods Pharmaceuticals Limited)

  FDA approved a lacosamide generic from Macleods Pharmaceuticals Limited under an Original Application (ANDA 208466).

• FDA approval · 2024-05-17
  FDA Approved: EPRONTIA — Supplemental Application (Azurity Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for EPRONTIA (topiramate) submitted by Azurity Pharmaceuticals, Inc.

• FDA approval · 2024-05-15
  FDA Approved: ACETAZOLAMIDE — Supplemental Application (Lifestar Pharma LLC)

  FDA has approved a supplemental application for acetazolamide submitted by Lifestar Pharma LLC.