Application Nr Approved Date Route Status External Links
NDA209936 None Intravenous None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Aliqopa Is Indicated For The Treatment Of Adult Patients With Relapsed Follicular Lymphoma (Fl) Who Have Received At Least Two Prior Systemic Therapies. Accelerated Approval Was Granted For This Indication Based On Overall Response Rate [See Clinical Studies ( 14.1 )] . Continued Approval For This Indication May Be Contingent Upon Verification And Description Of Clinical Benefit In A Confirmatory Trial. Aliqopa Is A Kinase Inhibitor Indicated For The Treatment Of Adult Patients With Relapsed Follicular Lymphoma (Fl) Who Have Received At Least Two Prior Systemic Therapies ( 1 ). Accelerated Approval Was Granted For This Indication Based On Overall Response Rate. Continued Approval For This Indication May Be Contingent Upon Verification And Description Of Clinical Benefit In A Confirmatory Trial.

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Copanlisib

Comments