← FDA DRUG APPROVALS

FDA NDA · NDA207103

IBRANCE

palbociclib

Sponsor: PFIZER

APPLICATION
NDA207103
TYPE
NDA
ORIGINAL APPROVAL
2015-02-03
LATEST ACTION
2026-06-24
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

IBRANCE · ReferencePrescription
PALBOCICLIB 125MG · CAPSULE · ORAL
IBRANCE · ReferencePrescription
PALBOCICLIB 75MG · CAPSULE · ORAL
IBRANCE · ReferencePrescription
PALBOCICLIB 100MG · CAPSULE · ORAL

Approval history

2026-06-24Efficacy · Supplement 24 · standard — Letter ↗AP
2025-09-16Efficacy · Supplement 23 · standard — Label ↗AP
2025-04-23Efficacy · Supplement 20 · standard — Label ↗AP
2025-03-06Labeling · Supplement 21 · standard — Letter ↗AP
2024-12-20Labeling · Supplement 22 · standard — Letter ↗AP
2023-09-06Labeling · Supplement 18 · standard — Letter ↗AP
2023-09-06Efficacy · Supplement 17 · standard — Letter ↗AP
2022-12-13Efficacy · Supplement 15 · standard — Label ↗AP
2019-09-09Efficacy · Supplement 11 · standard — Letter ↗AP
2019-09-09Labeling · Supplement 12 · 901 required — Letter ↗AP
2019-04-04Efficacy · Supplement 8 · standard — Label ↗AP
2019-02-19Labeling · Supplement 10 · standard — Label ↗AP
2018-02-06Efficacy · Supplement 7 · standard — Label ↗AP
2017-03-31Efficacy · Supplement 4 · priority — Letter ↗AP
2016-02-19Efficacy · Supplement 2 · priority — Review ↗AP
2015-12-17Manufacturing (CMC) · Supplement 1 · priorityAP
2015-02-03Type 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 →