Infantile Spasms

• FDA approval · 2024-09-12
  FDA Approved: VIGABATRIN — Supplemental Application (Carnegie Pharmaceuticals LLC)

  FDA approved a supplemental application for Vigabatrin filed by Carnegie Pharmaceuticals LLC.

• FDA approval · 2024-09-12
  FDA Approved: VIGABATRIN — Supplemental Application (Aurobindo Pharma Limited)

  The FDA approved a supplemental application to add Aurobindo Pharma Limited as an approved manufacturer of Vigabatrin.

• FDA approval · 2024-09-12
  FDA Approved: SABRIL — Supplemental Application (Lundbeck Pharmaceuticals LLC)

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

• FDA approval · 2024-09-12
  FDA Approved: VIGABATRIN — Supplemental Application (Dr. Reddys Laboratories Inc.,)

  FDA approved a supplemental application for Vigabatrin from Dr. Reddy's Laboratories Inc. (ANDA 211481).

• FDA approval · 2024-09-12
  FDA Approved: VIGABATRIN — Supplemental Application (Amneal Pharmaceuticals NY LLC)

  The FDA approved a supplemental application for Vigabatrin from Amneal Pharmaceuticals NY LLC to market a generic Vigabatrin product.

• Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
• FDA approval · 2024-09-12
  FDA Approved: VIGABATRIN — Supplemental Application (Actavis Pharma, Inc.)

  FDA approved Actavis Pharma, Inc.'s supplemental application for Vigabatrin (ANDA 209822).

• FDA approval · 2024-09-12
  FDA Approved: VIGADRONE — Supplemental Application (Upsher-Smith Laboratories, LLC)

  The FDA approved a supplemental application for VIGADRONE (vigabatrin) by Upsher-Smith Laboratories, LLC under ANDA 210196.

• FDA approval · 2024-09-12
  FDA Approved: VIGABATRIN — Supplemental Application (Cipla USA, Inc.)

  FDA approves a supplemental application for vigabatrin submitted by Cipla USA, Inc. The approval updates the drug's labeling and/or indicati…

• FDA approval · 2024-09-12
  FDA Approved: VIGABATRIN — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for Vigabatrin from Aurobindo Pharma Limited under an ANDA, granting approval for a generic form of …

• FDA approval · 2024-09-12
  FDA Approved: VIGABATRIN FOR ORAL SOLUTION — Supplemental Application (Camber Pharmaceuticals, Inc.)

  FDA approved a supplemental application to Camber Pharmaceuticals for Vigabatrin for oral solution, enabling a generic oral form of Vigabatr…

• FDA approval · 2024-09-12
  FDA Approved: VIGADRONE — Supplemental Application (Upsher-Smith Laboratories, LLC)

  The FDA approved a supplemental application for Vigadrone (vigabatrin) from Upsher-Smith Laboratories, confirming an approved supplement to …

• FDA approval · 2024-06-17
  FDA Approved: VIGAFYDE — Original Application (Upsher-Smith Laboratories, LLC)

  FDA approves VIGAFYDE (vigabatrin) from Upsher-Smith in an original NDA; the product is indicated for certain seizure disorders, including i…

• FDA approval · 2023-10-11
  FDA Approved: VIGABATRIN — Supplemental Application (Par Health USA, LLC)

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

• FDA approval · 2023-06-29
  FDA Approved: VIGADRONE — Original Application (Upsher-Smith Laboratories, LLC)

  The FDA approved Upsher-Smith Laboratories' original application for Vigadrone (vigabatrin), a generic form of the anticonvulsant vigabatrin…

• 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…

• 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 …

• 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.