MYALEPT (METRELEPTIN)
Summary
FDA approved MYALEPT (METRELEPTIN) by CHIESI FARMACEUTICI SPA. BLA (Biologic) approval (REMS) on 2025-09-17. INJECTABLE, INJECTION.
Details
Source
Drug Approval
External ID
BLA125390-29
Action Date
2025-09-17
Status
Approved
Category
drug
Product Code
BLA (Biologic)
Product Description
MYALEPT (generic: METRELEPTIN), INJECTABLE, INJECTION. Application: BLA125390
Company
Context & Analysis
CHIESI FARMACEUTICI SPA has 2 FDA actions in our database.
Frequently Asked Questions
How often does CHIESI FARMACEUTICI SPA have FDA actions?
CHIESI FARMACEUTICI SPA has 2 FDA actions in our database, including 0 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "BLA125390-29" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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