Epilepsy

• FDA approval · 2024-02-26
  FDA Approved: GABAPENTIN — Original Application (Camber Pharmaceuticals, Inc.)

  FDA approval of Gabapentin in an original application for Camber Pharmaceuticals, establishing a generic version of Gabapentin.

• FDA approval · 2024-02-26
  FDA Approved: GABAPENTIN — Original Application (Epic Pharma, LLC)

  FDA approved the original application for gabapentin from Epic Pharma, LLC, introducing a generic gabapentin product to the market.

• FDA approval · 2024-02-22
  FDA Approved: OXCARBAZEPINE — Original Application (Ajanta Pharma USA Inc.)

  The FDA approved Ajanta Pharma USA Inc.'s generic oxcarbazepine through an original application. It is indicated for the treatment of partia…

• FDA approval · 2024-02-20
  FDA Approved: GABAPENTIN — Supplemental Application (Rising Pharma Holdings, Inc.)

  FDA approved a supplemental application for gabapentin from Rising Pharma Holdings, Inc., authorizing changes to the approved generic produc…

• FDA approval · 2024-02-14
  FDA Approved: OXCARBAZEPINE — Original Application (Kanchan Healthcare Inc)

  FDA approves the generic oxcarbazepine under an original application by Kanchan Healthcare Inc.

• Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
• FDA approval · 2024-02-13
  FDA Approved: LACOSAMIDE — Original Application (Sintetica US LLC)

  FDA approves a lacosamide generic product from Sintetica US LLC under Original Application (ANDA 217311).

• FDA approval · 2024-02-12
  FDA Approved: LEVETIRACETAM IN SODIUM CHLORIDE — Original Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved Hikma Pharmaceuticals USA Inc.'s generic levetiracetam in sodium chloride injection under an Original Application.

• FDA approval · 2024-02-01
  FDA Approved: PHENYTEK — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for PHENYTEK (extended phenytoin sodium) from Mylan Pharmaceuticals Inc.

• FDA approval · 2024-01-29
  FDA Approved: CARBAMAZEPINE — Supplemental Application (ANI Pharmaceuticals, Inc.)

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

• FDA approval · 2024-01-29
  FDA Approved: CARBAMAZEPINE — Supplemental Application (Chartwell RX, LLC)

  FDA approved a supplemental application to permit Chartwell RX, LLC to market a generic carbamazepine product under an ANDA.

• FDA approval · 2024-01-29
  FDA Approved: CARBAMAZEPINE — Supplemental Application (Zydus Pharmaceuticals (USA) Inc.)

  FDA approved a supplemental application for carbamazepine from Zydus Pharmaceuticals (USA) Inc., updating the approved generic product.

• FDA approval · 2024-01-29
  FDA Approved: CARBAMAZEPINE — Supplemental Application (Rising Pharma Holdings, Inc.)

  FDA approved a supplemental application for carbamazepine by Rising Pharma Holdings, Inc.

• FDA approval · 2024-01-24
  FDA Approved: LEVETIRACETAM — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  FDA approved a supplemental application for levetiracetam (generic) submitted by Lupin Pharmaceuticals, Inc. under the ANDA.

• FDA approval · 2024-01-24
  FDA Approved: LEVETIRACETAM — Supplemental Application (BluePoint Laboratories)

  FDA approved a supplemental application for levetiracetam, a generic anti-seizure medication, from BluePoint Laboratories.

• FDA approval · 2024-01-24
  FDA Approved: LEVETIRACETAM — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for levetiracetam by Lupin Pharmaceuticals, Inc., supporting a generic product. This action upda…

• FDA approval · 2024-01-24
  FDA Approved: LEVETIRACETAM — Supplemental Application (NorthStar RxLLC)

  FDA approved a supplemental application for levetiracetam submitted by NorthStar RxLLC.

• FDA approval · 2024-01-24
  FDA Approved: LEVETIRACETAM ER — Supplemental Application (Westminster Pharmaceuticals, LLC)

  FDA approved a supplemental application for LEVETIRACETAM ER from Westminster Pharmaceuticals, LLC.

• FDA approval · 2024-01-24
  FDA Approved: GABAPENTIN — Original Application (Zydus Pharmaceuticals USA Inc.)

  FDA approves the Gabapentin original ANDA from Zydus Pharmaceuticals USA Inc.

• FDA approval · 2024-01-24
  FDA Approved: LACOSAMIDE — Original Application (Aurobindo Pharma Limited)

  FDA approved Aurobindo Pharma Limited's lacosamide Original Application (ANDA), enabling the marketing of a generic lacosamide product. Laco…

• FDA approval · 2024-01-23
  FDA Approved: PRIMIDONE — Original Application (Carnegie Pharmaceuticals LLC)

  FDA approved the original ANDA for primidone from Carnegie Pharmaceuticals LLC. Primidone is an anticonvulsant used in the treatment of cert…

• FDA approval · 2024-01-18
  FDA Approved: TOPIRAMATE — Supplemental Application (Zydus Lifesciences Limited)

  FDA approved a supplemental application for Topiramate from Zydus Lifesciences Limited. The action updates the product labeling and may expa…

• FDA approval · 2024-01-17
  FDA Approved: GABAPENTIN — Original Application (Camber Pharmaceuticals, Inc.)

  FDA approved Camber Pharmaceuticals' original application for gabapentin, a generic version of the anticonvulsant used for partial seizures …

• FDA approval · 2024-01-12
  FDA Approved: LEVETIRACETAM — Supplemental Application (Granules Pharmaceuticals Inc.)

  The FDA approved a supplemental application for levetiracetam from Granules Pharmaceuticals Inc., authorizing an additional formulation/stre…

• FDA approval · 2024-01-09
  FDA Approved: CARBAMAZEPINE — Supplemental Application (Upsher-Smith Laboratories, LLC)

  FDA approved a supplemental application for carbamazepine by Upsher-Smith Laboratories, with changes to its approved labeling and indication…

• FDA approval · 2024-01-04
  FDA Approved: TROKENDI XR — Supplemental Application (Supernus Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for TROKENDI XR (topiramate) filed by Supernus Pharmaceuticals, Inc., updating the product's lab…