← FDA DRUG APPROVALS

FDA NDA · NDA209935

KISQALI FEMARA CO-PACK

letrozole and ribociclib

Sponsor: NOVARTIS

APPLICATION
NDA209935
TYPE
NDA
ORIGINAL APPROVAL
2017-05-04
LATEST ACTION
2026-07-01
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

KISQALI FEMARA CO-PACK (COPACKAGED) · ReferencePrescription
LETROZOLE 2.5MG, RIBOCICLIB SUCCINATE EQ 200MG BASE · TABLET · ORAL

Approval history

2026-07-01Efficacy · Supplement 33 · priority — Letter ↗AP
2025-09-16Manufacturing (CMC) · Supplement 31 — Letter ↗AP
2025-07-28Labeling · Supplement 30 · standard — Label ↗AP
2025-02-11Labeling · Supplement 29 · standard — Letter ↗AP
2024-09-17Efficacy · Supplement 27 · standard — Letter ↗AP
2024-09-03Manufacturing (CMC) · Supplement 28 — Letter ↗AP
2023-08-24Labeling · Supplement 25 · standard — Letter ↗AP
2022-10-03Efficacy · Supplement 21 · standard — Letter ↗AP
2022-05-04Labeling · Supplement 19 · standard — Letter ↗AP
2021-12-10Efficacy · Supplement 14 · standard — Label ↗AP
2021-09-15Labeling · Supplement 13 · standard — Letter ↗AP
2020-07-06Efficacy · Supplement 8 · standard — Label ↗AP
2020-01-21Labeling · Supplement 6 · standard — Letter ↗AP
2019-09-09Labeling · Supplement 7 · standard — Letter ↗AP
2019-02-13Efficacy · Supplement 2 · priority — Label ↗AP
2018-04-23Labeling · Supplement 1 · standard — Label ↗AP
2017-05-04Type 4 - New Combination · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

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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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