Tuberous Sclerosis Complex-associated Subependymal Giant Cell Astrocytoma

• 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 · 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.