Belinostat
Belinostat is listed in the FDA National Drug Code directory with 4 NDC codes, marketed under brand name including Beleodaq. Available dosage forms: powder, injection, powder, lyophilized, for solution.
Drug Details
- Generic Name
- Belinostat
- Brand Names
- Beleodaq
- Application Number
- NDA206256
- Sponsor
- Curia New York, Inc.
- NDC Codes
- 4
- Dosage Forms
- POWDER, INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Routes
- INTRAVENOUS
- Active Ingredients
- BELINOSTAT
Indications and Usage
1 INDICATIONS AND USAGE Beleodaq is indicated for the treatment of adult patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). This indication is approved under accelerated approval based on tumor response rate and duration of response [ see Clinical Studies ( 14 )]. An improvement in survival or disease-related symptoms has not been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trial. Beleodaq is a histone deacetylase inhibitor indicated for the treatment of adult patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). This indication is approved under accelerated approval based on tumor response rate and duration of response. An improvement in survival or disease-related symptoms has not been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trial.( 1 )