Infantile Spasms

• CLINICAL_TRIALS trial_result · 2023-06-02
  Clinical Trial Update: A Randomized, Controlled Trial of Ganaxolone in Patients With Infantile Spasms [Phase 2]

  Phase 2 randomized trial of ganaxolone in infants with infantile spasms has been completed; results posted in 2023.

• FDA approval · 2023-04-28
  FDA Approved: VIGABATRIN — Original Application (Carnegie Pharmaceuticals LLC)

  FDA approved the original application for a generic vigabatrin (VIGABATRIN) by Carnegie Pharmaceuticals LLC. Vigabatrin is used to treat cer…

• CLINICAL_TRIALS withdrawal · 2023-04-20
  Clinical Trial Update: A Study to Evaluate Safety and Efficacy of AMZ002 Treatment, Compared With Vigabatrin in Participants With Infantile Spasms [Phase 3]

  Phase 3 trial comparing AMZ002 to vigabatrin for infantile spasms was withdrawn.

• FDA approval · 2023-03-02
  FDA Approved: VIGABATRIN — Original Application (Zydus Lifesciences Limited)

  FDA approves Zydus Lifesciences Limited's original ANDA for Vigabatrin, allowing a generic version of the anti-epileptic drug. The approval …

• CLINICAL_TRIALS trial_result · 2023-02-16
  Clinical Trial Update: A Study of Orally Administered JBPOS0101 in Refractory Infantile Spasms Patients [Phase 2]

  Phase 2 study of orally administered JBPOS0101 in refractory infantile spasms was terminated; results have been posted.

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• FDA approval · 2022-11-08
  FDA Approved: VIGABATRIN — Supplemental Application (Amneal Pharmaceuticals NY LLC)

  FDA approved a supplemental application for Vigabatrin from Amneal Pharmaceuticals NY LLC, enabling a generic version of the drug.

• FDA approval · 2022-10-28
  FDA Approved: VIGABATRIN — Supplemental Application (Cipla USA, Inc.)

  FDA approved a supplemental application for Vigabatrin submitted by Cipla USA, Inc., updating the product's labeling.

• FDA approval · 2022-10-26
  FDA Approved: VIGABATRIN — Supplemental Application (Ascend Laboratories, LLC)

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

• FDA approval · 2022-10-25
  FDA Approved: VIGABATRIN FOR ORAL SOLUTION — Supplemental Application (Camber Pharmaceuticals, Inc.)

  The FDA approved Camber Pharmaceuticals' supplemental application to market Vigabatrin as an oral solution, expanding the available dosage f…

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

  FDA approved a supplemental application for Vigabatrin (VIGABATRIN) submitted by Zydus Pharmaceuticals (USA) Inc.

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

  FDA approved a supplemental application for Vigabatrin by Amneal Pharmaceuticals NY LLC under ANDA210155, updating its regulatory status.

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

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

• FDA approval · 2022-10-12
  FDA Approved: VIGADRONE — Supplemental Application (Upsher-Smith Laboratories, LLC)

  FDA approved a supplemental application for VIGADRONE (vigabatrin) from Upsher-Smith Laboratories, LLC, authorizing the continued marketing …

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

  FDA approved a supplemental application for Vigabatrin submitted by Actavis Pharma, Inc. under ANDA 209822.

• 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…

• 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…