Epilepsy

• FDA approval · 2023-03-01
  FDA Approved: TOPIRAMATE — Original Application (Endo USA, Inc.)

  FDA approved Endo USA, Inc.'s original ANDA for a generic Topiramate product.

• FDA approval · 2023-02-24
  FDA Approved: DEPAKOTE SPRINKLES — Supplemental Application (AbbVie Inc.)

  FDA approved a supplemental application for Depakote Sprinkles (divalproex sodium) submitted by AbbVie Inc.

• FDA approval · 2023-02-24
  FDA Approved: DEPAKOTE ER — Supplemental Application (AbbVie Inc.)

  The FDA approved a supplemental application for Depakote ER (divalproex sodium) submitted by AbbVie, expanding the NDA with additional regul…

• FDA approval · 2023-02-09
  FDA Approved: LACOSAMIDE — Original Application (Novadoz Pharmaceuticals LLC)

  FDA approves the original generic application for lacosamide by Novadoz Pharmaceuticals LLC.

• FDA approval · 2023-02-08
  FDA Approved: DIAZEPAM — Supplemental Application (Natco Pharma USA LLC)

  FDA approved Natco Pharma USA LLC's supplemental application for Diazepam (generic) under ANDA210363. This approval advances the generic Dia…

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• FDA approval · 2023-02-08
  FDA Approved: DIAZEPAM — Supplemental Application (Natco Pharma USA LLC)

  FDA approves a supplemental application for Diazepam by Natco Pharma USA LLC, approving a supplemental change to the generic diazepam produc…

• FDA approval · 2023-02-06
  FDA Approved: LACOSAMIDE — Original Application (Kanchan Healthcare Inc)

  FDA approved a generic lacosamide product under ANDA216461, produced by Kanchan Healthcare Inc. This adds a generic option for lacosamide in…

• FDA approval · 2023-01-31
  FDA Approved: LEVETIRACETAM — Original Application (Hp Halden Pharma AS)

  FDA approved the original application for Levetiracetam (Hp Halden Pharma AS), a generic formulation used to treat epilepsy.

• FDA approval · 2023-01-25
  FDA Approved: DIVALPROEX SODIUM — Supplemental Application (Ajanta Pharma USA Inc.)

  FDA approves a supplemental application for divalproex sodium submitted by Ajanta Pharma USA Inc.

• FDA approval · 2023-01-23
  FDA Approved: ACETAZOLAMIDE — Supplemental Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.)

  FDA approved a supplemental application for Acetazolamide (generic) submitted by Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals In…

• FDA approval · 2023-01-18
  FDA Approved: LACOSAMIDE — Supplemental Application (XLCare Pharmaceuticals Inc.)

  The FDA approved a supplemental application for lacosamide submitted by XLCare Pharmaceuticals Inc., updating the product labeling under the…

• FDA approval · 2023-01-18
  FDA Approved: GABAPENTIN — Original Application (Advagen Pharma Ltd)

  FDA approved Advagen Pharma Ltd's gabapentin in an Original Application, granting a generic version of gabapentin (ANDA 216492).

• FDA approval · 2023-01-17
  FDA Approved: DIAZEPAM — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  The FDA approved a supplemental application for diazepam submitted by Hikma Pharmaceuticals USA Inc., marking regulatory action to support t…

• FDA approval · 2023-01-17
  FDA Approved: DIAZEPAM — Supplemental Application (Chartwell RX, LLC)

  FDA approved a supplemental application for diazepam oral solution concentrate from Chartwell RX, LLC, adding/confirming approval for this d…

• FDA approval · 2023-01-17
  FDA Approved: MIDAZOLAM — Supplemental Application (Steriscience Specialties Private Limited)

  FDA approved a supplemental application for Midazolam hydrochloride (Midazolam) by Steriscience Specialties Private Limited under an ANDA.

• FDA approval · 2023-01-17
  FDA Approved: CLONAZEPAM — Supplemental Application (Par Health USA, LLC)

  The FDA approved a supplemental application for clonazepam submitted by Par Health USA, LLC, supporting continued use of this generic benzod…

• FDA approval · 2023-01-17
  FDA Approved: CLONAZEPAM — Supplemental Application (Alembic Pharmaceuticals Inc.)

  FDA approved Alembic Pharmaceuticals' supplemental application for clonazepam, confirming approval of a generic clonazepam product.

• FDA approval · 2023-01-13
  FDA Approved: VALTOCO — Supplemental Application (Neurelis, Inc)

  FDA approved a supplemental application for VALTOCO (diazepam) by Neurelis, Inc.

• FDA approval · 2023-01-13
  FDA Approved: ONFI — Supplemental Application (Lundbeck Pharmaceuticals LLC)

  The FDA approved a supplemental application for ONFI (clobazam) submitted by Lundbeck Pharmaceuticals LLC.

• FDA approval · 2023-01-13
  FDA Approved: NAYZILAM — Supplemental Application (UCB, Inc.)

  FDA approved a supplemental application for Nayzilam (midazolam) from UCB, Inc.

• FDA approval · 2023-01-11
  FDA Approved: DIAZEPAM — Supplemental Application (Natco Pharma USA LLC)

  FDA approved a supplemental application for diazepam (generic) from Natco Pharma USA LLC under ANDA210363.

• FDA approval · 2023-01-06
  FDA Approved: BRIVARACETAM — Original Application (Aurobindo Pharma Limited)

  FDA approved a generic version of brivaracetam from Aurobindo Pharma Limited under an Original Application (ANDA 214848).

• FDA approval · 2023-01-05
  FDA Approved: LEVETIRACETAM — Supplemental Application (Prinston Pharmaceutical Inc.)

  FDA approves a supplemental application for levetiracetam from Prinston Pharmaceutical Inc., indicating an update or expansion to the existi…

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

  FDA approved a supplemental application for levetiracetam from ScieGen Pharmaceuticals, Inc. The approval pertains to the generic product in…

• FDA approval · 2023-01-05
  FDA Approved: LACOSAMIDE — Original Application (Aurobindo Pharma Limited)

  FDA granted approval for lacosamide as an Original Application for Aurobindo Pharma Limited, enabling a generic lacosamide product.