Epilepsy

• FDA approval · 2023-05-17
  FDA Approved: BRIVIACT — Supplemental Application (UCB, Inc.)

  The FDA approved a supplemental application for Briviact (brivaracetam) submitted by UCB, Inc., marking an approved modification to the exis…

• FDA approval · 2023-05-17
  FDA Approved: LEVETIRACETAM — Supplemental Application (Fresenius Kabi USA, LLC)

  FDA approved a supplemental application for levetiracetam from Fresenius Kabi USA, LLC. The approval covers a change to an already approved …

• FDA approval · 2023-05-08
  FDA Approved: PHENYTOIN INFATABS — Supplemental Application (Prasco Laboratories)

  FDA approved a supplemental application for Phenytoin Infatabs (phenytoin) from Prasco Laboratories. The approval updates the marketing auth…

• FDA approval · 2023-05-04
  FDA Approved: TOPIRAMATE — Original Application (Endo USA, Inc.)

  FDA approves Endo USA, Inc.'s original application for a generic Topiramate. Topiramate is used for epilepsy and migraine prophylaxis.

• FDA approval · 2023-05-03
  FDA Approved: TOPAMAX — Supplemental Application (Janssen Pharmaceuticals, Inc.)

  FDA approved Janssen's supplemental application for Topamax (topiramate) and updated the product labeling.

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• FDA approval · 2023-05-01
  FDA Approved: CLOBAZAM — Supplemental Application (Camber Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for CLOBAZAM (clobazam) submitted by Camber Pharmaceuticals, Inc. This action represents regulat…

• FDA approval · 2023-05-01
  FDA Approved: CLOBAZAM — Supplemental Application (Bionpharma Inc.)

  FDA approved a supplemental application for CLOBAZAM (clobazam) from Bionpharma Inc., under ANDA208819.

• FDA approval · 2023-05-01
  FDA Approved: METHSUXIMIDE — Original Application (ANI Pharmaceuticals, Inc.)

  The FDA approved ANI Pharmaceuticals' original application for methsuximide, a generic anticonvulsant used to treat absence seizures.

• FDA approval · 2023-04-28
  FDA Approved: VIMPAT — Supplemental Application (UCB, Inc.)

  FDA approved a supplemental application for VIMPAT (lacosamide) submitted by UCB, Inc., finalizing the regulatory action on the product.

• FDA approval · 2023-04-26
  FDA Approved: CLOBAZAM — Supplemental Application (Aurobindo Pharma Limited)

  FDA approves a supplemental application for CLOBAZAM by Aurobindo Pharma Limited, updating the regulatory status of this clobazam product.

• FDA approval · 2023-04-25
  FDA Approved: DIAZEPAM — Supplemental Application (Hospira, Inc.)

  FDA approved Hospira's supplemental application for diazepam (generic) under ANDA 071583. This represents a supplemental approval for a gene…

• FDA approval · 2023-03-31
  FDA Approved: PREGABALIN — Supplemental Application (ScieGen Pharmaceuticals, Inc)

  The FDA approved a supplemental application from ScieGen Pharmaceuticals, Inc. for a generic pregabalin product. The approval covers the sam…

• FDA approval · 2023-03-28
  FDA Approved: LACOSAMIDE — Supplemental Application (Fresenius Kabi USA, LLC)

  FDA approved a supplemental application for lacosamide submitted by Fresenius Kabi USA, LLC, updating the product's approval.

• FDA approval · 2023-03-28
  FDA Approved: LACOSAMIDE ORAL SOLUTION — Supplemental Application (Ascend Laboratories, LLC)

  The FDA approved a supplemental application to authorize lacosamide oral solution from Ascend Laboratories, expanding the product's dosage f…

• FDA approval · 2023-03-24
  FDA Approved: CARBAMAZEPINE — Original Application (Ajanta Pharma USA Inc.)

  FDA approved Ajanta Pharma USA's original ANDA for carbamazepine (generic anticonvulsant). This marks the availability of a generic carbamaz…

• FDA approval · 2023-03-17
  FDA Approved: GABAPENTIN — Supplemental Application (TIME CAP LABORATORIES, INC)

  FDA approved a supplemental application for gabapentin by Time Cap Laboratories, Inc., resulting in an approved update to the product's regu…

• FDA approval · 2023-03-14
  FDA Approved: OXCARBAZEPINE — Supplemental Application (EPIC PHARMA, LLC)

  The FDA approved a supplemental application for oxcarbazepine filed by Epic Pharma, LLC.

• FDA approval · 2023-03-10
  FDA Approved: TOPIRAMATE — Original Application (Teva Pharmaceuticals, Inc.)

  FDA approved Teva's original application for topiramate, making a generic version of the anti-seizure and migraine-prophylaxis medication av…

• FDA approval · 2023-03-08
  FDA Approved: TOPIRAMATE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved the supplemental application for Topiramate from Aurobindo Pharma Limited, confirming regulatory clearance for its generic Topi…

• FDA approval · 2023-03-08
  FDA Approved: ZONISAMIDE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for Zonisamide from Aurobindo Pharma Limited (ANDA077645). The approval pertains to changes to the g…

• FDA approval · 2023-03-07
  FDA Approved: TOPIRAMATE — Supplemental Application (NorthStar RxLLC)

  The FDA approved a supplemental application for Topiramate submitted by NorthStar RxLLC. The approval indicates changes to the existing prod…

• FDA approval · 2023-03-03
  FDA Approved: TIAGABINE HYDROCHLORIDE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for tiagabine hydrochloride from Teva Pharmaceuticals USA, Inc., indicating a labeling-related regul…

• FDA approval · 2023-03-03
  FDA Approved: LEVETIRACETAM IN SODIUM CHLORIDE — Supplemental Application (Nexus Pharmaceuticals LLC)

  FDA approved a supplemental application for levetiracetam in sodium chloride from Nexus Pharmaceuticals LLC to market a generic injectable f…

• FDA approval · 2023-03-02
  FDA Approved: CARBAMAZEPINE ER — Original Application (Epic Pharma, LLC)

  FDA approves the first original-application generic Carbamazepine ER from Epic Pharma, LLC under ANDA 216235. This extended-release formulat…

• FDA approval · 2023-03-01
  FDA Approved: OXCARBAZEPINE — Supplemental Application (Amneal Pharmaceuticals LLC)

  The FDA approved a supplemental application for oxcarbazepine filed by Amneal Pharmaceuticals LLC.