← FDA DRUG APPROVALS

FDA NDA · NDA209092

KISQALI

ribociclib

Sponsor: NOVARTIS

APPLICATION
NDA209092
TYPE
NDA
ORIGINAL APPROVAL
2017-03-13
LATEST ACTION
2026-07-01
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

KISQALI · ReferencePrescription
RIBOCICLIB SUCCINATE EQ 200MG BASE · TABLET · ORAL

Approval history

2026-07-01Efficacy · Supplement 27 · priority — Letter ↗AP
2025-09-16Manufacturing (CMC) · Supplement 25 — Letter ↗AP
2025-07-28Labeling · Supplement 24 · standard — Label ↗AP
2025-02-11Labeling · Supplement 23 · standard — Letter ↗AP
2024-09-17Efficacy · Supplement 18 · priority — Letter ↗AP
2024-09-03Manufacturing (CMC) · Supplement 20 — Letter ↗AP
2024-07-22Efficacy · Supplement 19 · standard — Letter ↗AP
2023-08-24Labeling · Supplement 16 · standard — Letter ↗AP
2022-10-03Efficacy · Supplement 13 · standard — Letter ↗AP
2021-12-10Efficacy · Supplement 8 · standard — Label ↗AP
2021-09-15Labeling · Supplement 9 · standard — Letter ↗AP
2020-07-06Efficacy · Supplement 5 · standard — Label ↗AP
2020-01-21Labeling · Supplement 3 · standard — Letter ↗AP
2019-09-09Labeling · Supplement 4 · standard — Letter ↗AP
2018-07-18Efficacy · Supplement 1 · priority — Letter ↗AP
2017-03-13Type 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 →