← FDA DRUG APPROVALS

FDA BLA · BLA761184

NGENLA

somatrogon-ghla

Sponsor: PFIZER IRELAND PHARMACEUTICALS

APPLICATION
BLA761184
TYPE
BLA
ORIGINAL APPROVAL
2023-06-27
LATEST ACTION
2026-04-29
ROUTE
SUBCUTANEOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

NGENLAPrescription
SOMATROGON-GHLA 60MG · INJECTABLE · INJECTION
NGENLAPrescription
SOMATROGON-GHLA 24MG · INJECTABLE · INJECTION

Approval history

2026-04-29Labeling · Supplement 8 · standard — Label ↗AP
2025-07-09Labeling · Supplement 6 · standard — Letter ↗AP
2024-07-05Manufacturing (CMC) · Supplement 3AP
2023-12-27Manufacturing (CMC) · Supplement 1 — Letter ↗AP
2023-06-27Type 1 - New Molecular Entity · Original · standard — 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.

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