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FDA-&-EMA-New-Drug Approvals(Mid-2020 Recap)-insert

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Napp Pharmaceuticals

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Chinaplas 2020

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Napp Pharmaceuticals Announces European Commission Approval of Invokana® (canagliflozin) Label Update to Reflect Improved Renal Outcomes in...

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Lead Product(s): Canagliflozin

Therapeutic Area: Nephrology Product Name: Invokana

Highest Development Status: Approved Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable July 02, 2020

Details:

The European Commission approval is based on the Canagliflozin and Renal Endpoints in Diabetes with Established Nephropathy Clinical Evaluation Phase III renal outcomes trial, which was stopped early based on the achievement of a pre-specified efficacy criterion.