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Agency wants more data on Invokana dosing regimens
December 13, 2013
By: Gil Roth
President, Pharma & Biopharma Outsourcing Association
Janssen Research & Development, LLC, a Johnson & Johnson subsidiary, has received from a complete response letter (CRL) from the FDA regarding its NDA for a fixed-dose combination (FDC) of canagliflozin and immediate-release metformin to treat adults with type 2 diabetes. The CRL 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 canag...
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