← FDA DRUG APPROVALS

FDA BLA · BLA021839

INCRELEX

mecasermin

Sponsor: IPSEN INC

APPLICATION
BLA021839
TYPE
BLA
ORIGINAL APPROVAL
2005-08-30
LATEST ACTION
2025-07-09
ROUTE
SUBCUTANEOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

INCRELEXPrescription
MECASERMIN RECOMBINANT 40MG/4ML (10MG/ML) · INJECTABLE · SUBCUTANEOUS

Approval history

2025-07-09Labeling · Supplement 33 · standard — Letter ↗AP
2024-03-15Efficacy · Supplement 31 · standard — Letter ↗AP
2023-10-20Labeling · Supplement 27 · standard — Letter ↗AP
2019-12-03Labeling · Supplement 24 · standard — Letter ↗AP
2019-01-18Labeling · Supplement 21 · standard — Letter ↗AP
2016-03-15Labeling · Supplement 17 · standard — Label ↗AP
2014-06-03Labeling · Supplement 16 · standard — Label ↗AP
2013-01-16Manufacturing (CMC) · Supplement 14 · priorityAP
2012-09-13Labeling · Supplement 10 · unknown — Label ↗AP
2012-06-14Labeling · Supplement 12 · unknown — Letter ↗AP
2011-02-16Labeling · Supplement 7 · standard — Letter ↗AP
2005-08-30Type 1 - New Molecular Entity · Original · priority — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Biologics industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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