Infantile Spasms

• FDA approval · 2020-04-17
  FDA Approved: VIGABATRIN — Supplemental Application (Par Health USA, LLC)

  The FDA approved a supplemental application for Vigabatrin submitted by Par Health USA, LLC. This action updates the regulatory status for V…

• FDA approval · 2020-04-17
  FDA Approved: VIGADRONE — Supplemental Application (Upsher-Smith Laboratories, LLC)

  The FDA approved a supplemental application for VIGADRONE (vigabatrin) from Upsher-Smith Laboratories, LLC.

• FDA approval · 2020-04-17
  FDA Approved: VIGABATRIN — Supplemental Application (Dr. Reddys Laboratories Inc.,)

  FDA approved a supplemental application for Vigabatrin from Dr. Reddy's Laboratories, marking an update to the product's approval status.

• FDA approval · 2020-04-17
  FDA Approved: VIGABATRIN — Supplemental Application (Amneal Pharmaceuticals NY LLC)

  FDA approves Amneal Pharmaceuticals NY LLC's supplemental application for Vigabatrin (ANDA210155). This action updates the approval for the …

• 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.

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• 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.

• FDA approval · 2019-09-12
  FDA Approved: SABRIL — Supplemental Application (Lundbeck Pharmaceuticals LLC)

  The FDA approved a supplemental application for Sabril (vigabatrin) from Lundbeck Pharmaceuticals LLC, typically resulting in updates to lab…

• FDA approval · 2019-09-12
  FDA Approved: VIGABATRIN — Supplemental Application (Amneal Pharmaceuticals NY LLC)

  FDA approved a supplemental application for Vigabatrin from Amneal Pharmaceuticals NY LLC.

• FDA approval · 2019-09-12
  FDA Approved: VIGABATRIN — Supplemental Application (Actavis Pharma, Inc.)

  FDA approved Actavis Pharma's supplemental application for Vigabatrin, updating the existing approval for the drug.

• FDA approval · 2019-09-12
  FDA Approved: VIGABATRIN — Supplemental Application (Dr. Reddys Laboratories Inc.,)

  FDA approved a supplemental application for Vigabatrin submitted by Dr. Reddy's Laboratories Inc., enabling continued availability of the ge…

• FDA approval · 2019-07-31
  FDA Approved: SABRIL — Supplemental Application (Lundbeck Pharmaceuticals LLC)

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

• FDA approval · 2019-05-31
  FDA Approved: SABRIL — Supplemental Application (Lundbeck Pharmaceuticals LLC)

  FDA approved a supplemental application for Sabril (vigabatrin) from Lundbeck Pharmaceuticals LLC. The action completes an approved suppleme…

• FDA approval · 2019-05-30
  FDA Approved: VIGABATRIN — Supplemental Application (Par Health USA, LLC)

  FDA approved a supplemental application for Vigabatrin filed by Par Health USA, LLC.

• FDA approval · 2019-05-30
  FDA Approved: VIGABATRIN — Supplemental Application (Dr. Reddys Laboratories Inc.,)

  FDA approved a supplemental application for Vigabatrin from Dr. Reddy's Laboratories Inc., marking an approval related to a generic Vigabatr…

• FDA approval · 2019-01-14
  FDA Approved: VIGABATRIN — Original Application (Actavis Pharma, Inc.)

  FDA page documents Actavis Pharma's original application for a generic Vigabatrin product, seeking approval to market a generic version.

• 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 · 2018-08-21
  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 · 2018-06-21
  FDA Approved: VIGADRONE — Original Application (Upsher-Smith Laboratories, LLC)

  FDA approved the original generic application for Vigabatrin under the brand VIGADRONE by Upsher-Smith Laboratories, expanding access to the…

• FDA approval · 2018-03-13
  FDA Approved: VIGABATRIN — Original Application (Amneal Pharmaceuticals NY LLC)

  FDA approved Amneal's generic version of vigabatrin under an Original Application (ANDA 210155), enabling marketing of the drug for its esta…

• FDA approval · 2017-04-27
  FDA Approved: SABRIL — Supplemental Application (Lundbeck Pharmaceuticals LLC)

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

• FDA approval · 2017-04-27
  FDA Approved: VIGABATRIN — Original Application (Par Health USA, LLC)

  FDA approves Vigabatrin original Abbreviated New Drug Application for Par Health USA, LLC (generic entry).

• FDA approval · 2016-06-21
  FDA Approved: SABRIL — Supplemental Application (Lundbeck Pharmaceuticals LLC)

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

• FDA approval · 2015-11-03
  FDA Approved: SABRIL — Supplemental Application (Lundbeck Pharmaceuticals LLC)

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

• FDA approval · 2012-12-11
  FDA Approved: SABRIL — Supplemental Application (Lundbeck Pharmaceuticals LLC)

  The FDA approved Lundbeck's supplemental application for SABRIL (vigabatrin), updating the labeling per NDA020427. This approval reflects ch…