Infantile Spasms

• FDA approval · 2022-10-12
  FDA Approved: VIGABATRIN — Supplemental Application (Cipla USA, Inc.)

  FDA approved a supplemental application for Vigabatrin by Cipla USA, Inc., under ANDA211592 (VIGABATRIN).

• FDA approval · 2022-10-12
  FDA Approved: VIGABATRIN FOR ORAL SOLUTION — Supplemental Application (Camber Pharmaceuticals, Inc.)

  The FDA approved Camber Pharmaceuticals' supplemental application for Vigabatrin as an oral solution, adding a new formulation of the antiep…

• FDA approval · 2022-10-12
  FDA Approved: VIGABATRIN — Supplemental Application (Dr. Reddys Laboratories Inc.,)

  FDA approved a supplemental application for Vigabatrin from Dr. Reddy's Laboratories, indicating an approved modification to the original AN…

• FDA approval · 2022-10-12
  FDA Approved: VIGABATRIN — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for Vigabatrin by Aurobindo Pharma Limited under ANDA213899.

• FDA approval · 2022-10-12
  FDA Approved: VIGABATRIN — Supplemental Application (Amneal Pharmaceuticals NY LLC)

  FDA granted supplemental approval for Vigabatrin from Amneal Pharmaceuticals NY LLC under ANDA210042, enabling a revised/expanded approval f…

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• FDA approval · 2022-10-12
  FDA Approved: VIGABATRIN — Supplemental Application (Ascend Laboratories, LLC)

  FDA approved a supplemental application for Vigabatrin submitted by Ascend Laboratories, LLC.

• FDA approval · 2022-10-12
  FDA Approved: VIGABATRIN — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for Vigabatrin submitted by Aurobindo Pharma Limited, indicating regulatory action to authorize this…

• FDA approval · 2022-10-12
  FDA Approved: VIGABATRIN — Supplemental Application (Hikma Pharmaceuticals USA Inc)

  FDA approved a supplemental application for Vigabatrin submitted by Hikma Pharmaceuticals USA Inc, representing an additional regulatory act…

• FDA approval · 2022-10-12
  FDA Approved: VIGABATRIN — Supplemental Application (Novadoz Pharmaceuticals LLC)

  FDA approved a supplemental application for vigabatrin filed by Novadoz Pharmaceuticals LLC.

• FDA approval · 2022-10-12
  FDA Approved: VIGABATRIN — Supplemental Application (Edenbridge Pharmaceuticals LLC.)

  FDA approved a supplemental application for Vigabatrin from Edenbridge Pharmaceuticals LLC. under ANDA 215109.

• FDA approval · 2022-09-07
  FDA Approved: VIGABATRIN — Original Application (Novadoz Pharmaceuticals LLC)

  The FDA approved the original Abbreviated New Drug Application for vigabatrin from Novadoz Pharmaceuticals LLC, yielding a generic version o…

• FDA approval · 2022-08-29
  FDA Approved: VIGABATRIN — Original Application (Hikma Pharmaceuticals USA Inc)

  FDA approved Hikma's generic Vigabatrin under an Original Application (ANDA 213104). This notice confirms approval of a generic Vigabatrin p…

• FDA approval · 2022-08-08
  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 · 2022-06-22
  FDA Approved: VIGABATRIN — Original Application (Amneal Pharmaceuticals NY LLC)

  FDA approves the original ANDA for Vigabatrin (Amneal Pharmaceuticals NY LLC) for the treatment of infantile spasms and refractory complex p…

• FDA approval · 2022-01-19
  FDA Approved: VIGABATRIN — Original Application (Zydus Pharmaceuticals (USA) Inc.)

  FDA approved the original application for vigabatrin by Zydus Pharmaceuticals (USA) Inc.

• FDA approval · 2021-10-20
  FDA Approved: SABRIL — Supplemental Application (Lundbeck Pharmaceuticals LLC)

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

• FDA approval · 2021-09-29
  FDA Approved: VIGABATRIN — Original Application (Aurobindo Pharma Limited)

  FDA approved an original ANDA for Vigabatrin from Aurobindo Pharma Limited, enabling generic availability of the drug.

• FDA approval · 2021-01-29
  FDA Approved: VIGABATRIN — Original Application (Dr. Reddys Laboratories Inc.,)

  FDA approves Dr. Reddy's Laboratories' original ANDA for vigabatrin, the generic form of this anticonvulsant.

• FDA approval · 2021-01-26
  FDA Approved: VIGABATRIN — Supplemental Application (Actavis Pharma, Inc.)

  FDA approved a supplemental application for Vigabatrin from Actavis Pharma, Inc., indicating an approval action related to an update to the …

• FDA approval · 2021-01-26
  FDA Approved: VIGABATRIN FOR ORAL SOLUTION — Original Application (Camber Pharmaceuticals, Inc.)

  FDA approved Vigabatrin for oral solution from Camber Pharmaceuticals as an original application, enabling a generic product for specified e…

• FDA approval · 2020-12-02
  FDA Approved: VIGABATRIN — Original Application (Ascend Laboratories, LLC)

  FDA approved Ascend Laboratories' original ANDA for vigabatrin (generic vigabatrin). This approval makes a generic version of vigabatrin ava…

• FDA approval · 2020-10-20
  FDA Approved: SABRIL — Supplemental Application (Lundbeck Pharmaceuticals LLC)

  The FDA approved a supplemental application for Sabril (vigabatrin) submitted by Lundbeck Pharmaceuticals LLC. The action updates the approv…

• FDA approval · 2020-10-02
  FDA Approved: VIGABATRIN — Supplemental Application (Dr. Reddys Laboratories Inc.,)

  FDA granted a supplemental approval for Vigabatrin by Dr. Reddys Laboratories Inc., initiating a new regulatory action related to the produc…

• FDA approval · 2020-10-02
  FDA Approved: VIGABATRIN — Supplemental Application (Cipla USA, Inc.)

  FDA approved a supplemental application for Vigabatrin by Cipla USA, Inc., granting an additional approval under the ANDA for Vigabatrin, ty…

• FDA approval · 2020-10-02
  FDA Approved: VIGADRONE — Supplemental Application (Upsher-Smith Laboratories, LLC)

  The FDA approved a supplemental application for Vigadrone (vigabatrin) from Upsher-Smith Laboratories, LLC. This action authorizes changes r…