← FDA DRUG APPROVALS

FDA BLA · BLA125164

MIRCERA

Sponsor: HOFFMAN-LA ROCHE

APPLICATION
BLA125164
TYPE
BLA
ORIGINAL APPROVAL
2007-11-14
LATEST ACTION
2024-06-04
ROUTE
INJECTION
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

MIRCERAPrescription
METHOXY POLYETHYLENE GLYCOL-EPOETIN BETA 0.6MG/KG · SOLUTION · INJECTION

Approval history

2024-06-04Labeling · Supplement 91 · standard — Letter ↗AP
2024-04-30Efficacy · Supplement 89 · standard — Label ↗AP
2023-03-31Efficacy · Supplement 87 · standard — Label ↗AP
2022-08-30Labeling · Supplement 86 · standard — Letter ↗AP
2018-06-07Efficacy · Supplement 78 · priority — Label ↗AP
2016-04-28Labeling · Supplement 72 · standard — Label ↗AP
2016-04-28Labeling · Supplement 73 · standard — Label ↗AP
2016-04-28Labeling · Supplement 71 · standard — Label ↗AP
2015-08-21Labeling · Supplement 70 · standard — Letter ↗AP
2014-10-01Labeling · Supplement 62 · standard — Label ↗AP
2008-07-07Labeling · Supplement 5 · standardAP
2007-11-14Type 1 - New Molecular Entity · Original · standard — Label ↗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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →