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US FDA receives new drug application from Janssen Research & Development for release formulation of Invokamet XR.

M2 EQUITYBITES-November 24, 2015-US FDA receives new drug application from Janssen Research & Development for release formulation of Invokamet XR

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The United States Food and Drug Administration has received a new drug application from Janssen Research & Development, a pharmaceutical company headquartered in Beerse, for extended release formulation of Invokamet XR to treat type 2 diabetes, it was reported yesterday.

The product is a once-daily fixed-dose combination of canagliflozin and metformin hydrochloride extended release (XR) in two tablets for glycaemic control in type two diabetics.

The FDA approved the product in August 2014 as a fixed-dose combination tablet featuring canagliflozin and immediate release metformin hydrochloride. The European Commission approved it in April 2014 under the name Vokanamet to treat adults with type two diabetes mellitus for improving glycaemic control.

Canagliflozin is currently being studied in various ongoing clinical trials, including in combination with metformin.

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Date:Nov 24, 2015
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