Congenital Generalized Lipodystrophy

• FDA approval · 2025-09-17
  FDA Approved: MYALEPT — Supplemental Application (Chiesi USA, Inc.)

  The FDA approved a supplemental application for MYALEPT (metreleptin) submitted by Chiesi USA, Inc.

• FDA approval · 2022-02-28
  FDA Approved: MYALEPT — Supplemental Application (Chiesi USA, Inc.)

  FDA approved a supplemental application for MYALEPT (metreleptin) submitted by Chiesi USA, Inc. The action updates the product's labeling/ap…

• FDA approval · 2019-12-13
  FDA Approved: MYALEPT — Supplemental Application (Chiesi USA, Inc.)

  The FDA approved a supplemental application for MYALEPT (metreleptin) filed by Chiesi USA, Inc. This action completes the review of a supple…

• FDA approval · 2017-12-11
  FDA Approved: MYALEPT — Supplemental Application (Chiesi USA, Inc.)

  The FDA approved a supplemental application for MYALEPT (metreleptin) filed by Chiesi USA, Inc.

• FDA approval · 2014-06-30
  FDA Approved: MYALEPT — Supplemental Application (Chiesi USA, Inc.)

  FDA approves a supplemental application for MYALEPT (metreleptin) submitted by Chiesi USA, Inc.

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• FDA approval · 2014-02-24
  FDA Approved: MYALEPT — Original Application (Chiesi USA, Inc.)

  This FDA overview documents the original approval of MYALEPT (metreleptin) by Chiesi USA, for leptin deficiency in patients with generalized…