asciminib
asciminib is listed in the FDA National Drug Code directory with 6 NDC codes, marketed under brand name including SCEMBLIX. Available dosage form: tablet, film coated.
Drug Details
- Generic Name
- asciminib
- Brand Names
- SCEMBLIX
- Application Number
- NDA215358
- Sponsor
- Novartis Pharma Stein AG
- NDC Codes
- 6
- Dosage Forms
- TABLET, FILM COATED
- Routes
- ORAL
- Active Ingredients
- ASCIMINIB HYDROCHLORIDE
Indications and Usage
1 INDICATIONS AND USAGE SCEMBLIX is indicated for the treatment of adult patients with: Newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP). This indication is approved under accelerated approval based on major molecular response rate [see Clinical Studies (14.1)] . Continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial(s). Previously treated Ph+ CML in CP. Ph+ CML in CP with the T315I mutation. SCEMBLIX is a kinase inhibitor indicated for the treatment of adult patients with: Newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP). This indication is approved under accelerated approval based on major molecular response rate. Continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial(s). ( 1 ) Previously treated Ph+ CML in CP. ( 1 ) Ph+ CML in CP with the T315I mutation. ( 1 )