Complete Response Letter from FDA for canagilflozin+ metformin-Janssen
Janssen R&D has received a Complete Response Letter regarding its New Drug Application from the FDA for a fixed-dose combination of canagliflozin and immediate-release metformin to treat adults with Type 2 Diabetes. The Complete Response Letter requested additional information to support the comparability of the twice-daily dosing regimen of canagliflozin -- as part of the canagliflozin and metformin FDC -- and the once-daily dosing of canagliflozin as a single agent. Janssen believes it can supply this information based on available clinical data.
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