Epilepsy

• FDA approval · 2018-11-20
  FDA Approved: VIGABATRIN — Original Application (Dr. Reddys Laboratories Inc.,)

  FDA approved the original abbreviated new drug application for Vigabatrin (generic) manufactured by Dr. Reddys Laboratories Inc.

• FDA approval · 2018-11-11
  FDA Approved: VIMPAT — Supplemental Application (UCB, Inc.)

  FDA approved a supplemental application for VIMPAT (lacosamide) from UCB, Inc., signaling an update to its labeling and indication.

• FDA approval · 2018-11-11
  FDA Approved: VIMPAT — Supplemental Application (UCB, Inc.)

  The FDA approved a supplemental application for VIMPAT (lacosamide) from UCB, Inc., updating the labeling for this antiepileptic drug.

• FDA approval · 2018-10-22
  FDA Approved: CLOBAZAM — Original Application (Amneal Pharmaceuticals NY LLC)

  FDA approved an original ANDA for CLOBAZAM from Amneal Pharmaceuticals NY LLC, authorizing the generic version of clobazam.

• FDA approval · 2018-10-22
  FDA Approved: CLOBAZAM — Original Application (Upsher-Smith Laboratories, LLC)

  FDA approved the original application for CLOBAZAM (clobazam) from Upsher-Smith Laboratories, LLC, as a generic anticonvulsant product. The …

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• FDA approval · 2018-10-22
  FDA Approved: CLOBAZAM — Original Application (Amneal Pharmaceuticals NY LLC)

  The FDA approved Amneal Pharmaceuticals' original ANDA for CLOBAZAM (clobazam), enabling the generic version of the epilepsy medication to b…

• FDA approval · 2018-10-22
  FDA Approved: CLOBAZAM — Original Application (Taro Pharmaceuticals U.S.A., Inc.)

  FDA approved CLOBAZAM (clobazam) through an Original Abbreviated New Drug Application for Taro Pharmaceuticals U.S.A., Inc., representing a …

• FDA approval · 2018-10-22
  FDA Approved: CLOBAZAM — Original Application (Bionpharma Inc.)

  FDA approves CLOBAZAM as a generic clobazam product via an Original Application (ANDA) for Bionpharma Inc.; submission status is AP.

• FDA approval · 2018-10-18
  FDA Approved: DILANTIN-125 — Supplemental Application (Viatris Specialty LLC)

  FDA approved a supplemental application for DILANTIN-125 (phenytoin) submitted by Viatris Specialty LLC. This action approves an update to a…

• FDA approval · 2018-10-18
  FDA Approved: ACETAZOLAMIDE — Original Application (Accord Healthcare Inc.)

  FDA approved Accord Healthcare Inc.'s Original Application for acetazolamide, confirming a generic version of the drug. The approval allows …

• FDA approval · 2018-10-16
  FDA Approved: GABAPENTIN — Original Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.)

  FDA approved the original generic application for gabapentin, enabling a generic version of the anticonvulsant for the same indications as t…

• FDA approval · 2018-09-27
  FDA Approved: FYCOMPA — Supplemental Application (Eisai Inc.)

  The FDA approved a supplemental application for FYCOMPA (perampanel) submitted by Eisai Inc. The approval updates the drug’s labeling/indica…

• FDA approval · 2018-09-19
  FDA Approved: CERETEC — Supplemental Application (Medi-Physics Inc. dba GE Healthcare.)

  FDA approved a supplemental application for CERETEC (technetium-99m exametazime), a radiopharmaceutical imaging agent, to modify/expand its …

• FDA approval · 2018-08-21
  FDA Approved: SABRIL — Supplemental Application (Lundbeck Pharmaceuticals LLC)

  FDA approved a supplemental application for Sabril (vigabatrin) submitted by Lundbeck Pharmaceuticals LLC.

• FDA approval · 2018-08-21
  FDA Approved: SABRIL — Supplemental Application (Lundbeck Pharmaceuticals LLC)

  The FDA approved a supplemental application for SABRIL (vigabatrin) by Lundbeck Pharmaceuticals LLC.

• FDA approval · 2018-07-23
  FDA Approved: LAMICTAL ODT — Supplemental Application (GlaxoSmithKline LLC)

  FDA approved a supplemental application for Lamictal ODT (lamotrigine) submitted by GlaxoSmithKline LLC.

• FDA approval · 2018-06-27
  FDA Approved: LAMICTAL — Supplemental Application (GlaxoSmithKline LLC)

  The FDA approved a supplemental application for Lamictal (lamotrigine) submitted by GlaxoSmithKline LLC to update the product labeling.

• FDA approval · 2018-06-27
  FDA Approved: LAMICTAL ODT — Supplemental Application (GlaxoSmithKline LLC)

  The FDA approved a supplemental application for LAMICTAL ODT (lamotrigine) from GlaxoSmithKline LLC. The approval updates the labeling for t…

• FDA approval · 2018-06-19
  FDA Approved: TOPAMAX — Supplemental Application (Janssen Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for Topamax (topiramate) submitted by Janssen Pharmaceuticals, Inc.

• FDA approval · 2018-05-10
  FDA Approved: BRIVIACT — Supplemental Application (UCB, Inc.)

  The FDA approved a supplemental application for BRIVIACT (brivaracetam) submitted by UCB, Inc.

• FDA approval · 2018-05-10
  FDA Approved: BRIVIACT — Supplemental Application (UCB, Inc.)

  FDA approved a supplemental application for Briviact (brivaracetam) submitted by UCB, Inc., which updates the product labeling.

• FDA approval · 2018-05-10
  FDA Approved: BRIVIACT — Supplemental Application (UCB, Inc.)

  FDA approved a supplemental application for BRIVIACT (brivaracetam) submitted by UCB, Inc.

• FDA approval · 2018-03-22
  FDA Approved: TRILEPTAL — Supplemental Application (Novartis Pharmaceuticals Corporation)

  The FDA approved a supplemental application for Trileptal (oxcarbazepine) submitted by Novartis Pharmaceuticals Corporation.

• FDA approval · 2018-03-20
  FDA Approved: TEGRETOL — Supplemental Application (Novartis Pharmaceuticals Corporation)

  The FDA approved a supplemental application for Tegretol (carbamazepine) from Novartis Pharmaceuticals Corporation.

• FDA approval · 2018-03-20
  FDA Approved: LEVETIRACETAM — Original Application (Method Pharmaceuticals, LLC)

  FDA approved the original application for a generic levetiracetam product from Method Pharmaceuticals, LLC, authorizing its market entry as …