Epilepsy

• FDA approval · 2022-07-26
  FDA Approved: ACETAZOLAMIDE — Supplemental Application (Strides Pharma Science Limited)

  FDA approved a supplemental application for acetazolamide filed by Strides Pharma Science Limited, authorizing an update to the generic prod…

• FDA approval · 2022-07-20
  FDA Approved: LEVETIRACETAM EXTENDED-RELEASE — Supplemental Application (Omnivium Pharmaceuticals LLC)

  The FDA approved a supplemental application to authorize an extended-release formulation of levetiracetam, manufactured by Omnivium Pharmace…

• FDA approval · 2022-07-18
  FDA Approved: LAMOTRIGINE — Supplemental Application (Jubilant Cadista Pharmacuticals Inc.)

  The FDA approved a supplemental application for a generic lamotrigine product from Jubilant Cadista Pharmaceuticals Inc.

• FDA approval · 2022-07-15
  FDA Approved: ZONISADE — Original Application (Azurity Pharmaceuticals, Inc.)

  FDA approved ZONISADE (zonisamide) via an original NDA for use in epilepsy, including partial-onset seizures.

• FDA approval · 2022-07-15
  FDA Approved: LEVETIRACETAM — Supplemental Application (Amneal Pharmaceuticals LLC)

  The FDA approves a supplemental application for levetiracetam from Amneal Pharmaceuticals LLC, authorizing generic production and distributi…

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• FDA approval · 2022-07-15
  FDA Approved: LEVETIRACETAM — Original Application (Novadoz Pharmaceuticals LLC)

  FDA approves Novadoz's original ANDA for Levetiracetam, establishing a generic anti-seizure medication. Indications include epilepsy-related…

• FDA approval · 2022-07-08
  FDA Approved: LAMOTRIGINE — Supplemental Application (Aurobindo Pharma Limited)

  The FDA approved a supplemental application for Lamotrigine by Aurobindo Pharma Limited, enabling a generic lamotrigine product.

• FDA approval · 2022-06-30
  FDA Approved: LAMOTRIGINE KIT — Supplemental Application (OWP Pharmaceuticals, Inc.)

  FDA approved a supplemental application for the Lamotrigine Kit from OWP Pharmaceuticals, authorizing the lamotrigine kit formulation.

• FDA approval · 2022-06-29
  FDA Approved: LACOSAMIDE — Original Application (Zydus Pharmaceuticals USA Inc.)

  FDA approved lacosamide via an original generic application (ANDA) for Zydus Pharmaceuticals USA Inc.

• FDA approval · 2022-06-28
  FDA Approved: PRIMIDONE — Original Application (Advagen Pharma Limited)

  FDA approved the original Abbreviated New Drug Application for PRIMIDONE (Primidone) from Advagen Pharma Limited.

• FDA approval · 2022-06-27
  FDA Approved: XCOPRI — Supplemental Application (SK Life Science, Inc.)

  The FDA approved a supplemental application for XCOPRI (cenobamate) from SK Life Science, expanding its label for seizure indications.

• FDA approval · 2022-06-17
  FDA Approved: LEVETIRACETAM — Supplemental Application (Amneal Pharmaceuticals LLC)

  The FDA approved a supplemental application from Amneal Pharmaceuticals LLC to market a generic version of Levetiracetam.

• FDA approval · 2022-06-16
  FDA Approved: CLORAZEPATE DIPOTASSIUM — Original Application (ANI Pharmaceuticals, Inc.)

  FDA approved ANI Pharmaceuticals' original application for a generic clorazepate dipotassium product.

• FDA approval · 2022-06-10
  FDA Approved: LAMOTRIGINE — Supplemental Application (Zydus Pharmaceuticals USA Inc.)

  The FDA approved a supplemental application for Lamotrigine from Zydus Pharmaceuticals USA Inc., indicating a post-approval modification to …

• FDA approval · 2022-06-09
  FDA Approved: BRIVARACETAM — Original Application (SolarisPharmaCorporation)

  FDA approved an abbreviated new drug application for brivaracetam (generic) by SolarisPharmaCorporation under ANDA214748, enabling a generic…

• FDA approval · 2022-05-31
  FDA Approved: LACOSAMIDE — Original Application (Camber Pharmaceuticals, Inc.)

  FDA approves Camber Pharmaceuticals' original application for lacosamide, enabling a generic lacosamide product to enter the market.

• FDA approval · 2022-05-27
  FDA Approved: LEVETIRACETAM — Original Application (ScieGen Pharmaceuticals, Inc.)

  The FDA approved an original Abbreviated New Drug Application (ANDA) for Levetiracetam from ScieGen Pharmaceuticals, establishing a generic …

• FDA approval · 2022-05-27
  FDA Approved: LEVETIRACETAM — Original Application (Ascend Laboratories, LLC)

  FDA approved a generic formulation of levetiracetam under an original application by Ascend Laboratories, LLC.

• FDA approval · 2022-05-25
  FDA Approved: ZONISAMIDE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  The FDA approved a supplemental application for zonisamide from Sun Pharmaceutical Industries, expanding the use or labeling of the product.…

• FDA approval · 2022-05-25
  FDA Approved: ZONISAMIDE — Supplemental Application (Exelan Pharmaceuticals, Inc.)

  FDA approved a supplemental application for Zonisamide from Exelan Pharmaceuticals, Inc., approving changes to the approved generic product …

• FDA approval · 2022-05-25
  FDA Approved: ZONISAMIDE — Supplemental Application (BluePoint Laboratories)

  The FDA approved a supplemental application for Zonisamide from BluePoint Laboratories (ANDA 077651).

• FDA approval · 2022-05-19
  FDA Approved: LACOSAMIDE ORAL SOLUTION — Original Application (Ascend Laboratories, LLC)

  The FDA approved an ANDA for lacosamide oral solution from Ascend Laboratories, LLC. This generic formulation is intended for use in treatin…

• FDA approval · 2022-05-03
  FDA Approved: LACOSAMIDE — Original Application (Fresenius Kabi USA, LLC)

  The FDA approved Fresenius Kabi USA, LLC's original application for lacosamide (ANDA214677), allowing the marketing of a generic lacosamide …

• FDA approval · 2022-04-07
  FDA Approved: LACOSAMIDE — Original Application (Sagent Pharmaceuticals)

  FDA approved Sagent Pharmaceuticals' original application for lacosamide (generic), enabling marketing of a generic lacosamide product for s…

• FDA approval · 2022-03-31
  FDA Approved: GABAPENTIN — Supplemental Application (Ascend Laboratories, LLC)

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