Epilepsy

• FDA approval · 2019-12-06
  FDA Approved: LAMOTRIGINE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for lamotrigine from Aurobindo Pharma Limited under ANDA090401, indicating an updated or added appro…

• FDA approval · 2019-12-06
  FDA Approved: LAMOTRIGINE — Supplemental Application (Ascend Laboratories, LLC)

  FDA approved a supplemental application for Lamotrigine from Ascend Laboratories, LLC.

• FDA approval · 2019-12-03
  FDA Approved: GABAPENTIN — Original Application (American Health Packaging)

  The FDA approved the original application for gabapentin from American Health Packaging, enabling a generic version of the anticonvulsant.

• FDA approval · 2019-12-03
  FDA Approved: VIGABATRIN — Original Application (Cipla USA, Inc.)

  FDA approved the original generic application for vigabatrin submitted by Cipla USA, establishing a generic version of the anticonvulsant.

• FDA approval · 2019-11-25
  FDA Approved: LEVETIRACETAM — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  The FDA approved Lupin Pharmaceuticals' supplemental application for levetiracetam, granting approval of a generic anti-epileptic drug.

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• FDA approval · 2019-11-22
  FDA Approved: DEPAKOTE SPRINKLES — Supplemental Application (AbbVie Inc.)

  FDA approved a supplemental application to introduce Depakote Sprinkles (divalproex sodium) from AbbVie, expanding the drug's dosage form op…

• FDA approval · 2019-11-21
  FDA Approved: XCOPRI — Original Application (SK Life Science, Inc.)

  FDA approved XCOPRI (cenobamate) from SK Life Science, Inc. in an original NDA for adjunctive treatment of partial-onset seizures in adults …

• FDA approval · 2019-11-21
  FDA Approved: LEVETIRACETAM — Supplemental Application (WG Critical Care, LLC)

  FDA approved a supplemental application for levetiracetam submitted by WG Critical Care, LLC.

• FDA approval · 2019-11-21
  FDA Approved: LAMOTRIGINE — Supplemental Application (Torrent Pharmaceuticals Limited)

  FDA approved a supplemental application for lamotrigine by Torrent Pharmaceuticals Limited.

• FDA approval · 2019-11-21
  FDA Approved: LAMOTRIGINE — Supplemental Application (Actavis Pharma, Inc.)

  FDA approved a supplemental application for lamotrigine from Actavis Pharma, Inc.

• FDA approval · 2019-11-06
  FDA Approved: DIAZEPAM — Supplemental Application (Natco Pharma USA LLC)

  The FDA approved a supplemental application for Diazepam from Natco Pharma USA LLC, granting approval of generic diazepam under ANDA210363.

• FDA approval · 2019-10-29
  FDA Approved: LAMOTRIGINE — Supplemental Application (Zydus Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for lamotrigine submitted by Zydus Pharmaceuticals USA Inc. The exact changes covered by the supplem…

• FDA approval · 2019-10-29
  FDA Approved: LAMOTRIGINE — Supplemental Application (Zydus Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for lamotrigine from Zydus Pharmaceuticals USA Inc.

• FDA approval · 2019-10-23
  FDA Approved: KEPPRA — Supplemental Application (UCB, Inc.)

  FDA approved a supplemental application for KEPPRA (levetiracetam) submitted by UCB, Inc. The approval updates the product labeling and may …

• FDA approval · 2019-10-23
  FDA Approved: KEPPRA XR — Supplemental Application (UCB, Inc.)

  FDA approves a supplemental application for KEPPRA XR (extended-release levetiracetam) from UCB, Inc., adding/confirming approval of the ext…

• FDA approval · 2019-10-21
  FDA Approved: FOSPHENYTOIN SODIUM — Supplemental Application (Amneal Pharmaceuticals LLC)

  The FDA approved a supplemental application for fosphenytoin sodium from Amneal Pharmaceuticals LLC.

• FDA approval · 2019-10-18
  FDA Approved: DIVALPROEX SODIUM — Original Application (Lupin Pharmaceuticals, Inc.)

  FDA approved Lupin Pharmaceuticals' divalproex sodium as a generic product under Original Application (ANDA 209286).

• FDA approval · 2019-09-25
  FDA Approved: LAMICTAL — Supplemental Application (GlaxoSmithKline LLC)

  The FDA approved a supplemental application for Lamictal (lamotrigine) submitted by GlaxoSmithKline LLC. The approval pertains to a suppleme…

• FDA approval · 2019-09-12
  FDA Approved: SABRIL — Supplemental Application (Lundbeck Pharmaceuticals LLC)

  The FDA approved a supplemental application for Sabril (vigabatrin) from Lundbeck Pharmaceuticals LLC, typically resulting in updates to lab…

• FDA approval · 2019-09-12
  FDA Approved: VIGABATRIN — Supplemental Application (Dr. Reddys Laboratories Inc.,)

  FDA approved a supplemental application for Vigabatrin submitted by Dr. Reddy's Laboratories Inc., enabling continued availability of the ge…

• FDA approval · 2019-08-14
  FDA Approved: LAMICTAL ODT — Supplemental Application (GlaxoSmithKline LLC)

  The FDA approved a supplemental application for LAMICTAL ODT (lamotrigine) from GlaxoSmithKline LLC.

• FDA approval · 2019-08-14
  FDA Approved: LAMICTAL — Supplemental Application (GlaxoSmithKline LLC)

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

• FDA approval · 2019-08-09
  FDA Approved: LEVETIRACETAM — Original Application (Micro Labs Limited)

  FDA approved a generic formulation of levetiracetam from Micro Labs Limited under ANDA211954.

• FDA approval · 2019-07-31
  FDA Approved: SABRIL — Supplemental Application (Lundbeck Pharmaceuticals LLC)

  FDA approved a supplemental application for SABRIL (vigabatrin) submitted by Lundbeck Pharmaceuticals LLC.

• FDA approval · 2019-06-28
  FDA Approved: CLONAZEPAM — Original Application (Alembic Pharmaceuticals Inc.)

  The FDA approved Alembic Pharmaceuticals' original application for a generic clonazepam product, expanding access to the generic formulation…