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BRIEF-Janssen submits supplemental new drug application to FDA
October 2, 2017 / 12:20 PM / 15 days ago

BRIEF-Janssen submits supplemental new drug application to FDA

Oct 2 (Reuters) - Johnson & Johnson

* Janssen submits supplemental new drug application (SNDA) to U.S. FDA seeking new indication for INVOKANA (canagliflozin) to reduce the risk of Major Adverse Cardiovascular Events (MACE) based on landmark canvas program

* Janssen Research & Development - supplemental new drug application also applies to INVOKANA’s fixed-dose combinations, INVOKAMET and INVOKAMET XR Source text for Eikon: Further company coverage:

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