← FDA DRUG APPROVALS

FDA BLA · BLA022505

EGRIFTA SV

tesamorelin

Sponsor: THERATECHNOLOGIES

APPLICATION
BLA022505
TYPE
BLA
ORIGINAL APPROVAL
2010-11-10
LATEST ACTION
2025-03-25
ROUTE
SUBCUTANEOUS
DOSAGE FORM
POWDER
MARKETING STATUS
Prescription

Products

EGRIFTAPrescription
TESAMORELIN ACETATE EQ 1MG BASE/VIAL · POWDER · SUBCUTANEOUS
EGRIFTAPrescription
TESAMORELIN ACETATE EQ 2MG BASE/VIAL · POWDER · SUBCUTANEOUS

Approval history

2025-03-25Manufacturing (CMC) · Supplement 20 · standard — Label ↗AP
2024-02-27Labeling · Supplement 18 · standard — Label ↗AP
2019-07-05Labeling · Supplement 12 · standard — Letter ↗AP
2019-07-05Labeling · Supplement 13 · standard — Label ↗AP
2019-01-18Labeling · Supplement 11 · standard — Letter ↗AP
2015-06-08Labeling · Supplement 7 · standard — Label ↗AP
2015-02-09Manufacturing (CMC) · Supplement 6 · standardAP
2014-12-15Manufacturing (CMC) · Supplement 5 · standardAP
2013-01-07Manufacturing (CMC) · Supplement 4 — Label ↗AP
2011-11-29Labeling · Supplement 3 · unknown — Label ↗AP
2011-11-29Manufacturing (CMC) · Supplement 1 · standard — Label ↗AP
2010-11-10Type 1 - New Molecular Entity · Original · standard — Summary Review ↗AP
—Manufacturing (CMC) · Supplement 10 · 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 →