Epilepsy

• FDA approval · 2020-02-28
  FDA Approved: CARBAMAZEPINE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a supplemental application for carbamazepine submitted by Sun Pharmaceutical Industries, Inc.

• FDA approval · 2020-02-28
  FDA Approved: CARBAMAZEPINE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  The FDA approved Sun Pharmaceutical Industries, Inc.'s supplemental application for carbamazepine, allowing an additional product authorizat…

• FDA approval · 2020-02-27
  FDA Approved: EPITOL — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  The FDA approved Teva's supplemental application for EPITOL (carbamazepine). This approval pertains to a supplemental filing for the product…

• FDA approval · 2020-02-21
  FDA Approved: DIVALPROEX SODIUM — Supplemental Application (Dr. Reddy's Laboratories Ltd)

  The FDA approved a supplemental application for divalproex sodium from Dr. Reddy's Laboratories Ltd, indicating an update to its labeling. T…

• FDA approval · 2020-02-20
  FDA Approved: DIVALPROEX SODIUM — Supplemental Application (Dr. Reddy's Laboratories Ltd)

  The FDA approved a supplemental application for divalproex sodium submitted by Dr. Reddy's Laboratories Ltd. This action denotes an approved…

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• FDA approval · 2020-02-14
  FDA Approved: TOPIRAMATE — Supplemental Application (Upsher-Smith Laboratories, LLC)

  The FDA approved a supplemental application for topiramate submitted by Upsher-Smith Laboratories, LLC, resulting in an update to the produc…

• FDA approval · 2020-02-12
  FDA Approved: LAMOTRIGINE — Supplemental Application (Endo USA, Inc.)

  FDA approved a supplemental application for Lamotrigine (generic) from Endo USA, Inc. under ANDA 204158, authorizing its marketing in the Un…

• FDA approval · 2020-02-10
  FDA Approved: LAMOTRIGINE EXTENDED RELEASE — Supplemental Application (Par Health USA, LLC)

  The FDA approved a supplemental application for Lamotrigine Extended Release, authorizing its extended-release formulation from Par Health U…

• FDA approval · 2020-02-07
  FDA Approved: LAMOTRIGINE EXTENDED-RELEASE — Supplemental Application (Par Health USA, LLC)

  FDA approved a supplemental application to approve Lamotrigine Extended-Release from Par Health USA, LLC. The product's labeling covers indi…

• FDA approval · 2020-02-05
  FDA Approved: LEVETIRACETAM — Supplemental Application (Torrent Pharmaceuticals Limited)

  The FDA approved a supplemental application for LEVETIRACETAM from Torrent Pharmaceuticals Limited. This reflects a supplemental approval un…

• FDA approval · 2020-01-30
  FDA Approved: DIVALPROEX SODIUM — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved Sun Pharmaceutical Industries' supplemental application for divalproex sodium, resulting in an approved change to the product u…

• FDA approval · 2020-01-29
  FDA Approved: LAMOTRIGINE — Supplemental Application (Dr. Reddys Laboratories Inc.)

  The FDA approved a supplemental application for Lamotrigine from Dr. Reddy's Laboratories Inc., authorizing this generic Lamotrigine product…

• FDA approval · 2020-01-29
  FDA Approved: LAMOTRIGINE — Supplemental Application (Advagen Pharma Limited)

  The FDA approved Advagen Pharma Limited's supplemental application for lamotrigine (generic lamotrigine). This is a supplemental approval fo…

• FDA approval · 2020-01-29
  FDA Approved: LAMOTRIGINE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a supplemental application for lamotrigine from Sun Pharmaceutical Industries, resulting in an approved generic lamotrigine pro…

• FDA approval · 2020-01-28
  FDA Approved: CEREBYX — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)

  FDA approved a supplemental application for CEREBYX (fosphenytoin sodium) submitted by Pfizer Laboratories Div Pfizer Inc.

• FDA approval · 2020-01-24
  FDA Approved: SABRIL — Supplemental Application (Lundbeck Pharmaceuticals LLC)

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

• FDA approval · 2020-01-17
  FDA Approved: LAMOTRIGINE — Supplemental Application (Unichem Pharmaceuticals (USA), Inc.)

  The FDA approved a supplemental application for lamotrigine filed by Unichem Pharmaceuticals (USA), Inc. This indicates a modification to th…

• FDA approval · 2020-01-15
  FDA Approved: LAMOTRIGINE — Supplemental Application (Alembic Pharmaceuticals Limited)

  FDA approved a supplemental application for lamotrigine submitted by Alembic Pharmaceuticals Limited under the ANDA program.

• FDA approval · 2020-01-14
  FDA Approved: DIVALPROEX SODIUM — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  FDA approved a supplemental application for divalproex sodium submitted by Lupin Pharmaceuticals, Inc.

• FDA approval · 2020-01-10
  FDA Approved: VALTOCO — Original Application (Neurelis, Inc)

  The FDA approved VALTOCO, a diazepam nasal spray from Neurelis, Inc., through an original NDA for the acute treatment of seizure clusters in…

• FDA approval · 2020-01-09
  FDA Approved: DIVALPROEX SODIUM — Supplemental Application (Unichem Pharmaceuticals (USA), Inc.)

  The FDA approved a supplemental application for divalproex sodium submitted by Unichem Pharmaceuticals (USA), Inc.

• FDA approval · 2020-01-03
  FDA Approved: DIVALPROEX SODIUM — Supplemental Application (Upsher-Smith Laboratories, LLC)

  The FDA approved a supplemental application for divalproex sodium from Upsher-Smith Laboratories, indicating a regulatory action related to …

• FDA approval · 2019-12-26
  FDA Approved: DIAZEPAM — Original Application (Natco Pharma USA LLC)

  FDA approved Natco Pharma USA LLC's original application for a generic diazepam product, enabling its marketing in the United States.

• FDA approval · 2019-12-17
  FDA Approved: LAMOTRIGINE — Supplemental Application (Alembic Pharmaceuticals Limited)

  The FDA approved a supplemental application from Alembic Pharmaceuticals Limited to manufacture and market lamotrigine chewable dispersible …

• FDA approval · 2019-12-06
  FDA Approved: LAMOTRIGINE KIT — Supplemental Application (OWP Pharmaceuticals, Inc.)

  FDA approves a supplemental application for the Lamotrigine Kit from OWP Pharmaceuticals, Inc., adding a lamotrigine kit product under an ap…