Congenital Hyperinsulinism

• FDA approval · 2025-03-26
  FDA Approved: VYKAT XR — Original Application (Soleno Therapeutics, Inc.)

  FDA approved VYKAT XR (diazoxide choline) through an Original Application for Soleno Therapeutics, indicated for congenital hyperinsulinism.

• FDA approval · 2024-07-18
  FDA Approved: PROGLYCEM — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for PROGLYCEM (diazoxide) from Teva Pharmaceuticals USA, Inc. This action updates the product's labe…

• FDA approval · 2022-12-22
  FDA Approved: PROGLYCEM — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for PROGLYCEM (diazoxide) submitted by Teva Pharmaceuticals USA, Inc., resulting in a label/indicati…

• FDA approval · 2015-09-18
  FDA Approved: PROGLYCEM — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for PROGLYCEM (diazoxide) from Teva Pharmaceuticals USA, Inc.

• FDA approval · 2013-11-21
  FDA Approved: PROGLYCEM — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  The FDA approved a supplemental NDA for PROGLYCEM (diazoxide) from Teva Pharmaceuticals USA, expanding or updating its labeling.

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• FDA approval · 2008-12-17
  FDA Approved: PROGLYCEM — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for PROGLYCEM (diazoxide) from Teva Pharmaceuticals USA, Inc., indicating an update to the product's…