Bosulif

Treats chronic phase Ph+ chronic myelogenous leukemia (CML), newly-diagnosed or resistant…. NDA 217729, held by Pf Prism Cv. Bosutinib Monohydrate.

As of Nov 13, 2026, NDA 217729 (Bosulif), held by Pf Prism Cv, was first approved by FDA on Sep 26, 2023, with 2 approved supplements and 0 published complete response letters.

First approved: Sep 26, 2023
Review: Priority
Supplements approved: 2
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

BOSULIF is indicated for the treatment of:

Adult and pediatric patients 1 year of age and older with chronic phase (CP) Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML), newly-diagnosed or resistant or intolerant to prior therapy.
Adult patients with accelerated phase (AP), or blast phase (BP) Ph+ CML with resistance or intolerance to prior therapy. BOSULIF is a kinase inhibitor indicated for the treatment of
adult and pediatric patients 1 year of age and older with chronic phase Ph+ chronic myelogenous leukemia (CML), newly-diagnosed or resistant or intolerant to prior therapy.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
Sep 26, 2023	Original applicationNew dosage form · Priority review	Approved	Review Label Letter

Products

2 strengths and forms


BosulifEQ 50MG BASE · capsule;oral	Bosutinib Monohydrate	RxReference drug
BosulifEQ 100MG BASE · capsule;oral	Bosutinib Monohydrate	RxReference drug

All 3 submissions, including labeling and manufacturing supplements


Mar 2, 2026	Supplement 2Labeling · Standard review	Approved	Label Letter
Dec 3, 2024	Supplement 1Labeling · Standard review	Approved	Label Letter
Sep 26, 2023	Original applicationNew dosage form · Priority review	Approved	Review Label Letter

Identifiers

Application: NDA 217729
Drugs@FDA: Overview at FDA
Company: PF PRISM CV

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters