Tuberous Sclerosis Complex

• FDA approval · 2025-10-16
  FDA Approved: ZTALMY — Supplemental Application (Immedica Pharma US Inc)

  FDA approves a supplemental application for ZTALMY (ganaxolone) submitted by Immedica Pharma US Inc.

• FDA approval · 2025-08-06
  FDA Approved: ZTALMY — Supplemental Application (Immedica Pharma US Inc)

  FDA approved a supplemental application for ZTALMY (ganaxolone) filed by Immedica Pharma US Inc.

• EMA approval · 2025-07-04
  EMA Authorised: Hyftor (sirolimus) — Plusultra pharma GmbH

  The EMA authorised Hyftor (sirolimus) by Plusultra pharma GmbH for angiofibroma and tuberous sclerosis complex with orphan medicine status.

• 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 · 2024-03-04
  FDA Approved: EPIDIOLEX — Supplemental Application (Jazz Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for Epidiolex (cannabidiol) from Jazz Pharmaceuticals.

• Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
• FDA approval · 2023-10-20
  FDA Approved: EPIDIOLEX — Supplemental Application (Jazz Pharmaceuticals, Inc.)

  FDA approved a supplemental application for Epidiolex (cannabidiol) submitted by Jazz Pharmaceuticals, Inc. The action updates the labeling …

• FDA approval · 2023-06-21
  FDA Approved: ZTALMY — Supplemental Application (Immedica Pharma US Inc)

  FDA approved a supplemental application for ZTALMY (ganaxolone) submitted by Immedica Pharma US Inc. The approval updates the product label …

• 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 · 2022-03-22
  FDA Approved: HYFTOR — Original Application (Nobelpharma America, LLC)

  FDA approved HYFTOR (sirolimus) under an original application from Nobelpharma America, expanding treatment options with a topical sirolimus…

• FDA approval · 2021-09-30
  FDA Approved: EPIDIOLEX — Supplemental Application (Jazz Pharmaceuticals, Inc.)

  The FDA has approved a supplemental application for Epidiolex (cannabidiol) from Jazz Pharmaceuticals, Inc., indicating an update to its app…

• FDA approval · 2019-05-22
  FDA Approved: EPIDIOLEX — Supplemental Application (Jazz Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for Epidiolex (cannabidiol) from Jazz Pharmaceuticals, updating the labeling to reflect the new …

• FDA approval · 2018-12-12
  FDA Approved: EPIDIOLEX — Supplemental Application (Jazz Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for Epidiolex (cannabidiol) submitted by Jazz Pharmaceuticals, Inc. The action updates the produ…

• FDA approval · 2014-07-01
  FDA Approved: AFINITOR DISPERZ — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application to add Afinitor Disperz, the dispersible tablet form of everolimus, expanding formulation options fo…