Epilepsy

• FDA approval · 2021-02-05
  FDA Approved: VALTOCO — Supplemental Application (Neurelis, Inc)

  The FDA approved a supplemental application for VALTOCO (diazepam) submitted by Neurelis, Inc.

• FDA approval · 2021-02-05
  FDA Approved: CLONAZEPAM — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for clonazepam from Teva Pharmaceuticals USA, Inc., to modify labeling.

• FDA approval · 2021-02-05
  FDA Approved: DIAZEPAM — Supplemental Application (Hospira, Inc.)

  FDA approved a supplemental application for diazepam from Hospira, Inc., under an ANDA, indicating regulatory approval of the requested chan…

• FDA approval · 2021-01-29
  FDA Approved: VIGABATRIN — Original Application (Dr. Reddys Laboratories Inc.,)

  FDA approves Dr. Reddy's Laboratories' original ANDA for vigabatrin, the generic form of this anticonvulsant.

• FDA approval · 2021-01-26
  FDA Approved: ZONISAMIDE — Original Application (Unichem Pharmaceuticals (USA), Inc.)

  FDA approved Unichem Pharmaceuticals (USA), Inc.'s generic zonisamide product through an Abbreviated New Drug Application, confirming a gene…

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• FDA approval · 2021-01-22
  FDA Approved: CLONAZEPAM — Supplemental Application (Par Health USA, LLC)

  The FDA approved a supplemental application for clonazepam from Par Health USA, LLC under an ANDA, signaling approval of a supplemental fili…

• FDA approval · 2021-01-19
  FDA Approved: LEVETIRACETAM — Supplemental Application (Prasco Laboratories)

  FDA approved a supplemental application for LEVETIRACETAM filed by Prasco Laboratories.

• FDA approval · 2021-01-19
  FDA Approved: LAMOTRIGINE — Original Application (Ajanta Pharma USA Inc.)

  FDA approves Ajanta Pharma USA Inc.'s original ANDA for lamotrigine, authorizing sale of a generic lamotrigine product for the same indicati…

• FDA approval · 2020-12-17
  FDA Approved: ELEPSIA XR 1000 MG — Supplemental Application (TRIPOINT THERAPEUTICS, LLC)

  FDA approved a supplemental application for ELEPSIA XR 1000 mg (levetiracetam) from Tripoint Therapeutics, LLC.

• FDA approval · 2020-12-16
  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. The action pertains to labeli…

• FDA approval · 2020-12-16
  FDA Approved: NEURONTIN — Supplemental Application (Parke-Davis Div of Pfizer Inc)

  The FDA approved a supplemental application for Neurontin (gabapentin) submitted by Parke-Davis Division of Pfizer Inc, indicating a change …

• FDA approval · 2020-12-02
  FDA Approved: VIGABATRIN — Original Application (Ascend Laboratories, LLC)

  FDA approved Ascend Laboratories' original ANDA for vigabatrin (generic vigabatrin). This approval makes a generic version of vigabatrin ava…

• FDA approval · 2020-11-27
  FDA Approved: LEVETIRACETAM ER — Original Application (Westminster Pharmaceuticals, LLC)

  FDA approved Westminster Pharmaceuticals' generic extended-release levetiracetam tablet (LEVETIRACETAM ER) under an Original Abbreviated New…

• FDA approval · 2020-11-18
  FDA Approved: TROKENDI XR — Supplemental Application (Supernus Pharmaceuticals, Inc.)

  FDA approved a supplemental application for Trokendi XR (topiramate) from Supernus Pharmaceuticals, indicating an update to its labeling.

• FDA approval · 2020-11-05
  FDA Approved: OXCARBAZEPINE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a supplemental application for oxcarbazepine from Sun Pharmaceutical Industries, Inc., resulting in an approved labeling change…

• FDA approval · 2020-10-30
  FDA Approved: VALPROIC ACID — Supplemental Application (ANI Pharmaceuticals, Inc.)

  FDA approved a supplemental application for Valproic Acid submitted by ANI Pharmaceuticals, Inc.

• FDA approval · 2020-10-27
  FDA Approved: GABAPENTIN — Supplemental Application (BluePoint Laboratories)

  The FDA approved a supplemental application for gabapentin from BluePoint Laboratories under an ANDA.

• FDA approval · 2020-10-20
  FDA Approved: SABRIL — Supplemental Application (Lundbeck Pharmaceuticals LLC)

  The FDA approved a supplemental application for Sabril (vigabatrin) submitted by Lundbeck Pharmaceuticals LLC. The action updates the approv…

• FDA approval · 2020-10-19
  FDA Approved: GABAPENTIN — Supplemental Application (QUALLENT PHARMACEUTICALS HEALTH LLC)

  FDA approved a supplemental application for gabapentin from Quallent Pharmaceuticals Health LLC. The approval may modify labeling or indicat…

• FDA approval · 2020-10-09
  FDA Approved: LAMICTAL — Supplemental Application (GlaxoSmithKline LLC)

  The FDA approved a supplemental application for Lamictal (lamotrigine) from GlaxoSmithKline LLC. The action typically involves changes to la…

• FDA approval · 2020-10-09
  FDA Approved: LAMICTAL — Supplemental Application (GlaxoSmithKline LLC)

  The FDA approved a supplemental application for Lamictal (lamotrigine) filed by GlaxoSmithKline, leading to changes in the product labeling.

• FDA approval · 2020-10-09
  FDA Approved: LAMICTAL ODT — Supplemental Application (GlaxoSmithKline LLC)

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

• FDA approval · 2020-10-09
  FDA Approved: LAMICTAL XR — Supplemental Application (GlaxoSmithKline LLC)

  FDA approved a supplemental application for Lamictal XR (lamotrigine) submitted by GlaxoSmithKline LLC. The action relates to Lamictal XR un…

• FDA approval · 2020-10-06
  FDA Approved: PHENYTOIN SODIUM — Supplemental Application (Acella Pharmaceuticals, LLC)

  FDA approved a supplemental application for phenytoin sodium from Acella Pharmaceuticals, LLC.

• FDA approval · 2020-10-02
  FDA Approved: LORAZEPAM — Supplemental Application (Amneal Pharmaceuticals LLC)

  FDA approved a supplemental application for Lorazepam from Amneal Pharmaceuticals LLC. The approval updates labeling/indication for the Lora…