← FDA DRUG APPROVALS

FDA BLA · BLA125390

MYALEPT

metreleptin

Sponsor: CHIESI FARMACEUTICI SPA

APPLICATION
BLA125390
TYPE
BLA
ORIGINAL APPROVAL
2014-02-24
LATEST ACTION
2025-09-17
ROUTE
SUBCUTANEOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

MYALEPTPrescription
METRELEPTIN 11.3MG · INJECTABLE · INJECTION

Approval history

2025-09-17REMS · Supplement 29 — Letter ↗AP
2023-03-31REMS · Supplement 25 — Letter ↗AP
2022-02-28Labeling · Supplement 24 · standard — Letter ↗AP
2021-06-09REMS · Supplement 23 — Letter ↗AP
2020-07-13REMS · Supplement 21 — Letter ↗AP
2020-05-15Labeling · Supplement 16 · standard — Letter ↗AP
2019-12-13Labeling · Supplement 17 · 901 required — Letter ↗AP
2018-12-21REMS · Supplement 14 — Letter ↗AP
2017-12-11REMS · Supplement 12 — Letter ↗AP
2015-09-22Labeling · Supplement 10 · 901 required — Label ↗AP
2015-08-27Labeling · Supplement 6 · standard — Label ↗AP
2014-06-30Labeling · Supplement 4 · standard — Label ↗AP
2014-02-24Type 1 - New Molecular Entity · Original · priority — Label ↗AP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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