Epilepsy

• FDA approval · 2020-07-11
  FDA Approved: LEVETIRACETAM — Supplemental Application (Eugia US LLC)

  FDA approved a supplemental application for levetiracetam in sodium chloride (LEVETIRACETAM IN SODIUM CHLORIDE) from Eugia US LLC, adding a …

• FDA approval · 2020-07-06
  FDA Approved: LEVETIRACETAM IN SODIUM CHLORIDE — Original Application (Nexus Pharmaceuticals LLC)

  FDA approved a generic levetiracetam in sodium chloride (ANDA) from Nexus Pharmaceuticals LLC.

• FDA approval · 2020-06-11
  FDA Approved: LEVETIRACETAM EXTENDED-RELEASE — Original Application (Omnivium Pharmaceuticals LLC)

  FDA approved an extended-release generic formulation of levetiracetam (ANDA212688) manufactured by Omnivium Pharmaceuticals LLC.

• FDA approval · 2020-06-09
  FDA Approved: LAMOTRIGINE — Supplemental Application (Amneal Pharmaceuticals LLC)

  FDA approved a supplemental application for Lamotrigine from Amneal Pharmaceuticals LLC, authorizing a new generic lamotrigine product.

• FDA approval · 2020-05-19
  FDA Approved: DEPAKOTE SPRINKLES — Supplemental Application (AbbVie Inc.)

  The FDA approved a supplemental application for Depakote Sprinkles (divalproex sodium) from AbbVie, updating labeling/indications for the pr…

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• FDA approval · 2020-05-19
  FDA Approved: DEPAKOTE ER — Supplemental Application (AbbVie Inc.)

  FDA approved a supplemental application for Depakote ER (divalproex sodium) submitted by AbbVie.

• FDA approval · 2020-04-24
  FDA Approved: CARBAMAZEPINE — Original Application (Rising Pharma Holdings, Inc.)

  The FDA approved Rising Pharma's original application for carbamazepine, a generic anticonvulsant used to treat epilepsy, trigeminal neuralg…

• FDA approval · 2020-04-21
  FDA Approved: VALPROIC ACID — Supplemental Application (Chartwell Governmental & Specialty RX, LLC.)

  FDA approved a supplemental application for valproic acid (generic) submitted by Chartwell Governmental & Specialty RX, LLC.

• FDA approval · 2020-04-20
  FDA Approved: LEVETIRACETAM — Supplemental Application (Dr.Reddy's Laboratories Inc)

  FDA approved a supplemental application for Levetiracetam Injection from Dr. Reddy's Laboratories Inc.

• FDA approval · 2020-04-20
  FDA Approved: LEVETIRACETAM — Supplemental Application (Eugia US LLC)

  FDA approved a supplemental application for a generic levetiracetam by Eugia US LLC, enabling its market introduction in the United States.

• FDA approval · 2020-04-17
  FDA Approved: VIGABATRIN — Supplemental Application (Par Health USA, LLC)

  The FDA approved a supplemental application for Vigabatrin submitted by Par Health USA, LLC. This action updates the regulatory status for V…

• FDA approval · 2020-04-17
  FDA Approved: VIGADRONE — Supplemental Application (Upsher-Smith Laboratories, LLC)

  The FDA approved a supplemental application for VIGADRONE (vigabatrin) from Upsher-Smith Laboratories, LLC.

• FDA approval · 2020-04-17
  FDA Approved: VIGABATRIN — Supplemental Application (Dr. Reddys Laboratories Inc.,)

  FDA approved a supplemental application for Vigabatrin from Dr. Reddy's Laboratories, marking an update to the product's approval status.

• FDA approval · 2020-04-17
  FDA Approved: VIGABATRIN — Supplemental Application (Amneal Pharmaceuticals NY LLC)

  FDA approves Amneal Pharmaceuticals NY LLC's supplemental application for Vigabatrin (ANDA210155). This action updates the approval for the …

• FDA approval · 2020-04-15
  FDA Approved: CARBAMAZEPINE — Original Application (NIVAGEN PHARMACEUTICALS, INC.)

  The FDA approved the original application for a generic carbamazepine product from NIVAGEN PHARMACEUTICALS, INC., marking the approval of th…

• FDA approval · 2020-04-13
  FDA Approved: ZONEGRAN — Supplemental Application (Advanz Pharma (US) Corp.)

  The FDA approved a supplemental application for ZONEGRAN (zonisamide) from Advanz Pharma (US) Corp. This approval authorizes a change to the…

• FDA approval · 2020-04-09
  FDA Approved: TOPIRAMATE — Supplemental Application (Zydus Lifesciences Limited)

  FDA approved a supplemental application for Topiramate from Zydus Lifesciences Limited under ANDA207382, granting additional approval relate…

• FDA approval · 2020-04-02
  FDA Approved: NEURONTIN — Supplemental Application (Parke-Davis Div of Pfizer Inc)

  The FDA approved a supplemental application for Neurontin (gabapentin) by Parke-Davis Div of Pfizer Inc, authorizing changes to its labeling…

• FDA approval · 2020-04-01
  FDA Approved: LAMOTRIGINE — Original Application (Zydus Pharmaceuticals USA Inc.)

  FDA approves the original abbreviated new drug application for lamotrigine from Zydus Pharmaceuticals USA Inc., making a generic version ava…

• FDA approval · 2020-03-25
  FDA Approved: GABAPENTIN — Supplemental Application (Ascend Laboratories, LLC)

  FDA approved a supplemental application for gabapentin submitted by Ascend Laboratories, LLC. The approval updates the generic gabapentin pr…

• FDA approval · 2020-03-20
  FDA Approved: PREGABALIN — Original Application (Chartwell RX, LLC)

  FDA approves Chartwell RX, LLC's original ANDA for pregabalin, establishing a generic version of the drug.

• FDA approval · 2020-03-16
  FDA Approved: ETHOSUXIMIDE — Supplemental Application (Chartwell RX, LLC)

  FDA approved a supplemental application for ethosuximide submitted by Chartwell RX, LLC, under the ANDA program.

• FDA approval · 2020-03-16
  FDA Approved: ETHOSUXIMIDE — Original Application (Epic Pharma, LLC)

  FDA approved Ethosuximide from Epic Pharma, LLC under an Abbreviated New Drug Application. It is approved as a generic treatment for absence…

• FDA approval · 2020-03-12
  FDA Approved: ZONISAMIDE — Supplemental Application (Exelan Pharmaceuticals, Inc.)

  FDA approved a supplemental application for zonisamide (Exelan Pharmaceuticals) under an ANDA.

• FDA approval · 2020-03-12
  FDA Approved: VIGABATRIN — Supplemental Application (Par Health USA, LLC)

  FDA approved a supplemental application for Vigabatrin (Par Health USA, LLC). This action approves changes to the product as requested by th…