Epilepsy

• FDA approval · 2021-11-16
  FDA Approved: TIAGABINE HYDROCHLORIDE — Original Application (Novadoz Pharmaceuticals LLC)

  FDA approved the original ANDA for tiagabine hydrochloride from Novadoz Pharmaceuticals LLC, granting a generic version for the treatment of…

• FDA approval · 2021-11-12
  FDA Approved: DIAZEPAM — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for Diazepam from Hikma Pharmaceuticals USA Inc. under an ANDA, reflecting a regulatory action on th…

• FDA approval · 2021-11-09
  FDA Approved: LAMOTRIGINE EXTENDED RELEASE — Supplemental Application (Par Health USA, LLC)

  The FDA approved a supplemental application for Lamotrigine Extended Release from Par Health USA, LLC, approving a generic extended-release …

• FDA approval · 2021-11-09
  FDA Approved: LAMOTRIGINE — Supplemental Application (NorthStar Rx LLC)

  FDA approved a supplemental application for lamotrigine (NorthStar Rx LLC) under an ANDA.

• FDA approval · 2021-11-09
  FDA Approved: LAMOTRIGINE — Supplemental Application (Torrent Pharmaceuticals Limited)

  FDA approved a supplemental application for Lamotrigine from Torrent Pharmaceuticals Limited, authorizing a modification to the approved gen…

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• FDA approval · 2021-11-05
  FDA Approved: EPRONTIA — Original Application (Azurity Pharmaceuticals, Inc.)

  FDA approves EPRONTIA (topiramate) from Azurity Pharmaceuticals, Inc. via an original application for approved indications in epilepsy and m…

• FDA approval · 2021-10-29
  FDA Approved: ZARONTIN — Supplemental Application (Parke-Davis Div of Pfizer Inc)

  The FDA approved a supplemental application for Zarontin (ethosuximide) from Parke-Davis Div of Pfizer Inc.

• FDA approval · 2021-10-29
  FDA Approved: LAMOTRIGINE — Supplemental Application (Advagen Pharma Limited)

  The FDA approved Advagen Pharma Limited's supplemental application for lamotrigine, confirming approval of the requested changes to this gen…

• FDA approval · 2021-10-22
  FDA Approved: DILANTIN — Supplemental Application (Viatris Specialty LLC)

  FDA approved a supplemental application for DILANTIN (extended phenytoin sodium) submitted by Viatris Specialty LLC, introducing the extende…

• FDA approval · 2021-10-20
  FDA Approved: CLOBAZAM — Supplemental Application (NorthStar RxLLC)

  The FDA approved a supplemental application for CLOBAZAM (clobazam) from NorthStar RxLLC under ANDA 209796, confirming its status as a gener…

• FDA approval · 2021-10-15
  FDA Approved: GABAPENTIN — Supplemental Application (QUALLENT PHARMACEUTICALS HEALTH LLC)

  FDA approved a supplemental application for gabapentin from Quallent Pharmaceuticals Health LLC, resulting in the approval of their generic …

• FDA approval · 2021-10-14
  FDA Approved: VIMPAT — Supplemental Application (UCB, Inc.)

  The FDA approved a supplemental application for VIMPAT (lacosamide) from UCB, Inc., to expand its approved indications for epilepsy.

• FDA approval · 2021-10-14
  FDA Approved: VIMPAT — Supplemental Application (UCB, Inc.)

  The FDA approved a supplemental application for VIMPAT (lacosamide) submitted by UCB, Inc.

• FDA approval · 2021-10-07
  FDA Approved: LEVETIRACETAM — Supplemental Application (Cranbury Pharmaceuticals, LLC)

  FDA approved a supplemental application for levetiracetam from Cranbury Pharmaceuticals, LLC under an Abbreviated New Drug Application. The …

• FDA approval · 2021-10-01
  FDA Approved: GABAPENTIN — Original Application (XLCare Pharmaceuticals, Inc.)

  FDA approved the original ANDA for gabapentin from XLCare Pharmaceuticals, enabling a generic version of the anticonvulsant.

• FDA approval · 2021-09-15
  FDA Approved: VIMPAT — Supplemental Application (UCB, Inc.)

  The FDA approved a supplemental application for Vimpat (lacosamide) by UCB, Inc.

• FDA approval · 2021-09-15
  FDA Approved: VIMPAT — Supplemental Application (UCB, Inc.)

  The FDA approved a supplemental application for VIMPAT (lacosamide) submitted by UCB, Inc. The approval pertains to changes to the drug's la…

• FDA approval · 2021-09-02
  FDA Approved: BRIVIACT — Supplemental Application (UCB, Inc.)

  FDA approved a supplemental application for BRIVIACT (brivaracetam) filed by UCB, Inc. The approval confirms modifications to the drug's lab…

• FDA approval · 2021-09-02
  FDA Approved: BRIVIACT — Supplemental Application (UCB, Inc.)

  FDA approved a supplemental application for Briviact (brivaracetam) filed by UCB, Inc., authorizing changes to its labeling or indication.

• FDA approval · 2021-08-27
  FDA Approved: BRIVIACT — Supplemental Application (UCB, Inc.)

  The FDA approved a supplemental application for Briviact (brivaracetam) submitted by UCB, Inc. The approval updates Briviact's labeling and/…

• FDA approval · 2021-08-27
  FDA Approved: BRIVIACT — Supplemental Application (UCB, Inc.)

  FDA approved a supplemental application for BRIVIACT (brivaracetam) submitted by UCB, Inc., to update its labeling. This approval formalizes…

• FDA approval · 2021-08-26
  FDA Approved: TOPIRAMATE — Original Application (Camber Pharmaceuticals, Inc.)

  The FDA approved Camber Pharmaceuticals' generic version of topiramate through an original ANDA.

• FDA approval · 2021-08-19
  FDA Approved: ACETAZOLAMIDE — Original Application (Advagen Pharma Ltd)

  FDA approved Advagen Pharma Ltd's generic acetazolamide under an original (ANDA) application, enabling marketing of a generic formulation of…

• FDA approval · 2021-07-13
  FDA Approved: LEVETIRACETAM — Supplemental Application (Sagent Pharmaceuticals)

  The FDA approved a supplemental application for levetiracetam submitted by Sagent Pharmaceuticals.

• FDA approval · 2021-06-29
  FDA Approved: ESLICARBAZEPINE ACETATE — Original Application (Dr.Reddys Laboratories Inc)

  FDA approved a generic eslicarbazepine acetate through an Original Application for Dr. Reddy's Laboratories, providing a generic option for …