Bosutinib
Bosutinib is listed in the FDA National Drug Code directory with 16 NDC codes, marketed under brand names including BOSULIF, Bosutinib. Available dosage forms: tablet, film coated, powder, capsule.
Drug Details
- Generic Name
- Bosutinib
- Brand Names
- BOSULIF, Bosutinib
- Application Number
- NDA203341
- Sponsor
- U.S. Pharmaceuticals
- NDC Codes
- 16
- Dosage Forms
- TABLET, FILM COATED, POWDER, CAPSULE
- Routes
- ORAL
- Active Ingredients
- BOSUTINIB MONOHYDRATE, BOSUTINIB
Indications and Usage
1 INDICATIONS AND USAGE Bosutinib tablets are indicated for the treatment of: Adult patients with chronic phase (CP) Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML), newly-diagnosed or resistant or intolerant to prior therapy [see Clinical Studies ( 14.1 , 14.2 )] . Adult patients with accelerated phase (AP), or blast phase (BP) Ph+ CML with resistance or intolerance to prior therapy [see Clinical Studies (14.2 )]. Pediatric use information is approved for PF PRISM CV’s BOSULIF ® (bosutinib) tablets. However, due to PF PRISM CV’s marketing exclusivity rights, this drug product is not labeled with that information. Bosutinib tablets are a kinase inhibitor indicated for the treatment of adult patients with chronic phase Ph+ chronic myelogenous leukemia (CML), newly-diagnosed or resistant or intolerant to prior therapy. ( 1 ) adult patients with accelerated, or blast phase Ph+ CML with resistance or intolerance to prior therapy. ( 1 )