← FDA DRUG APPROVALS

FDA BLA · BLA021106

SOMAVERT

pegvisomant

Sponsor: PHARMACIA

APPLICATION
BLA021106
TYPE
BLA
ORIGINAL APPROVAL
2003-03-25
LATEST ACTION
2023-07-27
ROUTE
SUBCUTANEOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

SOMAVERTPrescription
PEGVISOMANT 30MG/VIAL · INJECTABLE · SUBCUTANEOUS
SOMAVERTPrescription
PEGVISOMANT 20MG/VIAL · INJECTABLE · SUBCUTANEOUS
SOMAVERTPrescription
PEGVISOMANT 10MG/VIAL · INJECTABLE · SUBCUTANEOUS
SOMAVERTPrescription
PEGVISOMANT 25MG/VIAL · INJECTABLE · SUBCUTANEOUS
SOMAVERTPrescription
PEGVISOMANT 15MG/VIAL · INJECTABLE · SUBCUTANEOUS

Approval history

2023-07-27Efficacy · Supplement 74 · standard — Letter ↗AP
2021-08-20Labeling · Supplement 67 · standard — Label ↗AP
2021-08-20Labeling · Supplement 68 · standard — Label ↗AP
2019-09-24Labeling · Supplement 45 · standard — Letter ↗AP
2019-09-19Labeling · Supplement 64 · standard — Letter ↗AP
2019-08-16Labeling · Supplement 55 · standard — Letter ↗AP
2016-04-22Manufacturing (CMC) · Supplement 50 · priorityAP
2016-02-22Manufacturing (CMC) · Supplement 46 · priorityAP
2016-01-11Manufacturing (CMC) · Supplement 48 · priorityAP
2014-07-31Manufacturing (CMC) · Supplement 44 · priorityAP
2013-12-10Efficacy · Supplement 36 · standard — Letter ↗AP
2013-10-11Manufacturing (CMC) · Supplement 43 · priorityAP
2013-09-26Manufacturing (CMC) · Supplement 42 · priorityAP
2013-03-01Manufacturing (CMC) · Supplement 39 · priorityAP
2012-07-03Labeling · Supplement 31 · unknown — Label ↗AP
2010-07-20Labeling · Supplement 28 · unknown — Label ↗AP
2008-10-03Manufacturing (CMC) · Supplement 16AP
2008-08-18Labeling · Supplement 15 · standard — Letter ↗AP
2003-03-25Type 1 - New Molecular Entity · Original · priority — Letter ↗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 →