Epilepsy

• FDA approval · 2023-08-03
  FDA Approved: EXTENDED PHENYTOIN SODIUM — Supplemental Application (Amneal Pharmaceuticals LLC)

  The FDA approved a supplemental application for Extended Phenytoin Sodium from Amneal Pharmaceuticals LLC.

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

  FDA approved a supplemental application for an Extended Phenytoin Sodium product from Aurobindo Pharma Limited.

• FDA approval · 2023-08-03
  FDA Approved: ESLICARBAZEPINE ACETATE — Original Application (Camber Pharmaceuticals, Inc.)

  FDA approved Camber Pharmaceuticals' eslicarbazepine acetate as a generic, original-application product for adjunctive treatment of partial-…

• FDA approval · 2023-08-02
  FDA Approved: GABAPENTIN — Supplemental Application (Amneal Pharmaceuticals LLC)

  FDA approves a supplemental application for Gabapentin submitted by Amneal Pharmaceuticals LLC.

• FDA approval · 2023-07-31
  FDA Approved: DIVALPROEX SODIUM — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  FDA approved a supplemental application for divalproex sodium by Lupin Pharmaceuticals, Inc. under ANDA 078790.

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• FDA approval · 2023-07-28
  FDA Approved: DIVALPROEX SODIUM — Supplemental Application (BluePoint Laboratories)

  FDA approved a supplemental application for divalproex sodium submitted by BluePoint Laboratories, associated with an existing ANDA.

• FDA approval · 2023-07-28
  FDA Approved: LAMOTRIGINE — Supplemental Application (Dr. Reddys Laboratories Inc.)

  FDA approved a supplemental application for lamotrigine from Dr. Reddy's Laboratories Inc., under the ANDA process.

• FDA approval · 2023-07-21
  FDA Approved: LACOSAMIDE — Supplemental Application (ANI Pharmaceuticals, Inc.)

  FDA approved a supplemental application for lacosamide from ANI Pharmaceuticals, Inc., under ANDA 216151.

• FDA approval · 2023-07-19
  FDA Approved: GABAPENTIN — Original Application (Rising Pharma Holdings, Inc.)

  The FDA approved a generic gabapentin product from Rising Pharma Holdings, Inc. under an Original Application (ANDA217995).

• CLINICAL_TRIALS research · 2023-07-18
  Clinical Trial Update: Clinical Utility of Pediatric Whole Exome Sequencing [NA]

  Clinical trial update on the utility of pediatric whole exome sequencing for diagnosing developmental and neurological conditions; study com…

• FDA approval · 2023-07-17
  FDA Approved: TOPIRAMATE — Supplemental Application (Camber Pharmaceuticals, Inc.)

  The FDA approved Camber Pharmaceuticals' supplemental application for Topiramate (generic).

• FDA approval · 2023-07-13
  FDA Approved: OXCARBAZEPINE — Original Application (Apotex Corp.)

  The FDA approved Apotex Corp.'s generic oxcarbazepine under an Original Application (ANDA 213369). This approval makes the generic oxcarbaze…

• FDA approval · 2023-07-12
  FDA Approved: LACOSAMIDE — Supplemental Application (Camber Pharmaceuticals, Inc.)

  FDA approved Camber Pharmaceuticals' supplemental application for lacosamide, a generic antiseizure medication used as adjunctive therapy fo…

• FDA approval · 2023-07-10
  FDA Approved: DIAZEPAM — Supplemental Application (Oceanside Pharmaceuticals)

  FDA approved a supplemental application for Diazepam from Oceanside Pharmaceuticals.

• FDA approval · 2023-07-03
  FDA Approved: OXCARBAZEPINE — Original Application (Zydus Lifesciences Limited)

  FDA approved the Original Application for Oxcarbazepine from Zydus Lifesciences Limited, providing a generic option for the treatment of epi…

• CLINICAL_TRIALS trial_result · 2023-06-23
  Clinical Trial Update: Repeated TMS at Low Frequencies to Reduce Seizure Occurrence [NA]

  A clinical trial investigating repeated low-frequency TMS to reduce seizure occurrence was terminated; results were posted in 2023.

• FDA approval · 2023-06-16
  FDA Approved: LEVETIRACETAM — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  The FDA approved Lupin Pharmaceuticals' supplemental application for levetiracetam, enabling the marketing of a generic version of the drug.…

• FDA approval · 2023-06-16
  FDA Approved: RUFINAMIDE — Original Application (Aurobindo Pharma Limited)

  FDA approved Aurobindo Pharma Limited's original ANDA for a generic Rufinamide product, intended for seizures associated with Lennox-Gastaut…

• FDA approval · 2023-06-13
  FDA Approved: LEVETIRACETAM — Original Application (Granules Pharmaceuticals Inc.)

  FDA approved a generic version of levetiracetam from Granules Pharmaceuticals Inc. under an original ANDA (ANDA217878), expanding access to …

• FDA approval · 2023-06-08
  FDA Approved: LAMOTRIGINE — Supplemental Application (Unichem Pharmaceuticals (USA), Inc.)

  FDA approved a supplemental application for Lamotrigine from Unichem Pharmaceuticals (USA), Inc.

• FDA approval · 2023-05-26
  FDA Approved: LEVETIRACETAM — Supplemental Application (Civica, Inc.)

  The FDA approved Civica, Inc.'s supplemental application for levetiracetam (generic).

• FDA approval · 2023-05-23
  FDA Approved: LEVETIRACETAM — Supplemental Application (Eugia US LLC)

  FDA approved a supplemental application to authorize Levetiracetam in sodium chloride for intravenous use, manufactured by Eugia US LLC.

• FDA approval · 2023-05-23
  FDA Approved: LEVETIRACETAM — Supplemental Application (Dr.Reddy's Laboratories Inc)

  FDA approved a supplemental application for LEVETIRACETAM injection from Dr. Reddy's Laboratories.

• FDA approval · 2023-05-22
  FDA Approved: LEVETIRACETAM — Supplemental Application (Eugia US LLC)

  FDA approved a supplemental application for levetiracetam filed by Eugia US LLC.

• FDA approval · 2023-05-22
  FDA Approved: CLOBAZAM — Supplemental Application (Amneal Pharmaceuticals NY LLC)

  FDA approved a supplemental application for CLOBAZAM (clobazam) from Amneal Pharmaceuticals NY LLC, updating the approval of this generic pr…