Venclexta

Product manufactured by Abbvie Inc.

Application Nr Approved Date Route Status External Links
NDA208573 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Venclexta Is A Bcl-2 Inhibitor Indicated: For The Treatment Of Adult Patients With Chronic Lymphocytic Leukemia (Cll) Or Small Lymphocytic Lymphoma (Sll). ( 1.1 ) In Combination With Azacitidine, Or Decitabine, Or Low-Dose Cytarabine For The Treatment Of Newly-Diagnosed Acute Myeloid Leukemia (Aml) In Adults Who Are Age 75 Years Or Older, Or Who Have Comorbidities That Preclude Use Of Intensive Induction Chemotherapy. This Indication Is Approved Under Accelerated Approval Based On Response Rates. Continued Approval For This Indication May Be Contingent Upon Verification And Description Of Clinical Benefit In Confirmatory Trials. ( 1.2 ) 1.1 Chronic Lymphocytic Leukemia/small Lymphocytic Lymphoma Venclexta Is Indicated For The Treatment Of Adult Patients With Chronic Lymphocytic Leukemia (Cll) Or Small Lymphocytic Lymphoma (Sll). 1.2 Acute Myeloid Leukemia Venclexta Is Indicated In Combination With Azacitidine, Or Decitabine, Or Low-Dose Cytarabine For The Treatment Of Newly-Diagnosed Acute Myeloid Leukemia (Aml) In Adults Who Are Age 75 Years Or Older, Or Who Have Comorbidities That Preclude Use Of Intensive Induction Chemotherapy. This Indication Is Approved Under Accelerated Approval Based On Response Rates [See Clinical Studies ( 14.2 )] . Continued Approval For This Indication May Be Contingent Upon Verification And Description Of Clinical Benefit In Confirmatory Trials.

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Venetoclax VENETOCLAX ZINC150338755

Comments