← FDA DRUG APPROVALS

FDA NDA · NDA216059

JAYPIRCA

pirtobrutinib

Sponsor: LOXO ONCOL

APPLICATION
NDA216059
TYPE
NDA
ORIGINAL APPROVAL
2023-01-27
LATEST ACTION
2025-12-02
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

JAYPIRCA · ReferencePrescription
PIRTOBRUTINIB 50MG · TABLET · ORAL
JAYPIRCA · ReferencePrescription
PIRTOBRUTINIB 100MG · TABLET · ORAL

Approval history

2025-12-02Efficacy · Supplement 5 · standard — Label ↗AP
2024-06-04Labeling · Supplement 2 · 901 required — Letter ↗AP
2023-12-01Efficacy · Supplement 1 · priority — Label ↗AP
2023-01-27Type 1 - New Molecular Entity · Original · priority — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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