Epilepsy

• 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…

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• 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…

• FDA approval · 2019-12-06
  FDA Approved: LAMOTRIGINE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for lamotrigine from Aurobindo Pharma Limited under ANDA090401, indicating an updated or added appro…

• FDA approval · 2019-12-06
  FDA Approved: LAMOTRIGINE — Supplemental Application (Ascend Laboratories, LLC)

  FDA approved a supplemental application for Lamotrigine from Ascend Laboratories, LLC.

• FDA approval · 2019-12-03
  FDA Approved: GABAPENTIN — Original Application (American Health Packaging)

  The FDA approved the original application for gabapentin from American Health Packaging, enabling a generic version of the anticonvulsant.

• FDA approval · 2019-12-03
  FDA Approved: VIGABATRIN — Original Application (Cipla USA, Inc.)

  FDA approved the original generic application for vigabatrin submitted by Cipla USA, establishing a generic version of the anticonvulsant.

• CLINICAL_TRIALS trial_result · 2019-11-27
  Clinical Trial Update: Efficacy of Fluoxetine in Reducing Ictal Hypoventilation in Patients With Partial Epilepsy [NA]

  Clinical trial update evaluating fluoxetine for reducing ictal hypoventilation in patients with uncontrolled partial epilepsy has completed …

• FDA approval · 2019-11-25
  FDA Approved: LEVETIRACETAM — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  The FDA approved Lupin Pharmaceuticals' supplemental application for levetiracetam, granting approval of a generic anti-epileptic drug.

• FDA approval · 2019-11-22
  FDA Approved: DEPAKOTE SPRINKLES — Supplemental Application (AbbVie Inc.)

  FDA approved a supplemental application to introduce Depakote Sprinkles (divalproex sodium) from AbbVie, expanding the drug's dosage form op…

• FDA approval · 2019-11-21
  FDA Approved: XCOPRI — Original Application (SK Life Science, Inc.)

  FDA approved XCOPRI (cenobamate) from SK Life Science, Inc. in an original NDA for adjunctive treatment of partial-onset seizures in adults …

• FDA approval · 2019-11-21
  FDA Approved: LEVETIRACETAM — Supplemental Application (WG Critical Care, LLC)

  FDA approved a supplemental application for levetiracetam submitted by WG Critical Care, LLC.

• FDA approval · 2019-11-21
  FDA Approved: LAMOTRIGINE — Supplemental Application (Torrent Pharmaceuticals Limited)

  FDA approved a supplemental application for lamotrigine by Torrent Pharmaceuticals Limited.

• CLINICAL_TRIALS trial_result · 2019-11-21
  Clinical Trial Update: Modified Atkins Diet Versus Levetiracetam for Refractory Childhood Epilepsy [Phase 2, Phase 3]

  A clinical trial comparing Modified Atkins Diet to Levetiracetam for refractory childhood epilepsy (Phase 2/Phase 3).

• FDA approval · 2019-11-21
  FDA Approved: LAMOTRIGINE — Supplemental Application (Actavis Pharma, Inc.)

  FDA approved a supplemental application for lamotrigine from Actavis Pharma, Inc.