← FDA DRUG APPROVALS

FDA NDA · NDA216490

YORVIPATH

palopegteriparatide

Sponsor: ASCENDIS PHARMA BONE

APPLICATION
NDA216490
TYPE
NDA
ORIGINAL APPROVAL
2024-08-09
LATEST ACTION
2025-10-16
ROUTE
SUBCUTANEOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

YORVIPATH · ReferencePrescription
PALOPEGTERIPARATIDE EQ 0.42MG TERIPARATIDE/1.4ML (EQ 0.3MG TERIPARATIDE/ML) · SOLUTION · SUBCUTANEOUS
YORVIPATH · ReferencePrescription
PALOPEGTERIPARATIDE EQ 0.168MG TERIPARATIDE/0.56ML (EQ 0.168MG TERIPARATIDE/0.56ML) · SOLUTION · SUBCUTANEOUS
YORVIPATH · ReferencePrescription
PALOPEGTERIPARATIDE EQ 0.294MG TERIPARATIDE/0.98ML (EQ 0.294MG TERIPARATIDE/0.98ML) · SOLUTION · SUBCUTANEOUS

Approval history

2025-10-16Manufacturing (CMC) · Supplement 5 — Label ↗AP
2024-08-09Type 1 - New Molecular Entity · Original · priority — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma 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 →