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Non-Insulin Antidiabetics & Duration of Follow-Up and Duration of Use

Basic Details
Status
Complete
Last Updated
Tuesday, April 2, 2019
Health Outcome(s)
duration of follow-up
duration of use
Purpose
Methods, Characterization, or Development
Meets requirements of FD&C Act Sec 505(o) prior to requiring a PMR
No
Study Summary

Feasibility assessment that supported an ARIA sufficiency determination to replace a sponsor postmarketing requirement (PMR) safety study for canagliflozin and renal cell carcinoma.

Result(s) (1)
Duration of Follow-Up and Treatment for Non-Insulin Antidiabetic Drugs
Regulatory Link(s) (1)
Efficacy Supplement Approval Letter