Tuberous Sclerosis Complex-associated Renal Angiomyolipoma

• FDA approval · 2025-10-30
  FDA Approved: EVEROLIMUS — Original Application (Novugen Pharma (USA) LLC.)

  FDA approved a generic version of Everolimus from Novugen Pharma (USA) LLC under an Original Application (ANDA).

• FDA approval · 2024-04-30
  FDA Approved: EVEROLIMUS — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  The FDA approved a supplemental application for Everolimus submitted by Hikma Pharmaceuticals USA Inc. This action updates approved labeling…

• FDA approval · 2021-10-18
  FDA Approved: EVEROLIMUS — Original Application (Par Health USA, LLC)

  FDA approved Par Health USA, LLC's Original Application for EVEROLIMUS (a generic version of everolimus). The approval enables the generic p…

• FDA approval · 2021-02-11
  FDA Approved: EVEROLIMUS — Original Application (NorthStar RxLLC)

  FDA approved NorthStar RxLLC's original application (ANDA) for Everolimus, a generic version of the mTOR inhibitor. The approval enables a g…

• FDA approval · 2020-06-08
  FDA Approved: EVEROLIMUS — Original Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved Hikma Pharmaceuticals USA Inc.'s generic Everolimus under an Original Application, enabling the sale of a generic version of th…

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• FDA approval · 2020-02-13
  FDA Approved: AFINITOR — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application for Afinitor (everolimus) from Novartis Pharmaceuticals Corporation.

• FDA approval · 2018-04-12
  FDA Approved: EVEROLIMUS — Original Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved Hikma Pharmaceuticals USA Inc.'s Original Application for Everolimus, establishing a generic version of the branded drug. The a…

• FDA approval · 2016-10-12
  FDA Approved: ZORTRESS — Supplemental Application (Novartis Pharmaceuticals Corporation)

  The FDA approved a supplemental application for ZORTRESS (everolimus) submitted by Novartis Pharmaceuticals Corporation. The action likely a…

• FDA approval · 2015-07-01
  FDA Approved: AFINITOR DISPERZ — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application for Afinitor Disperz (everolimus) from Novartis. This approval updates its pediatric dispersible for…

• FDA approval · 2012-08-29
  FDA Approved: AFINITOR DISPERZ — Original Application (Novartis Pharmaceuticals Corporation)

  FDA approves AFINITOR DISPERZ (everolimus) under an Original Application for a dispersible tablet formulation.