Janssen submits NDA for extended release formulation of INVOKAMET for type 2 diabetics

|By:, SA News Editor

Janssen Research & Development (NYSE:JNJ) submits a New Drug Application (NDA) to the FDA for INVOKAMET XR, a once-daily fixed-dose combination of canagliflozin and metformin hydrochloride extended release (XR) in two tablets for glycemic control in type 2 diabetics.

INVOKAMET, cleared by the FDA in August 2014, is a fixed-dose combination tablet containing canagliflozin and immediate release metformin hydrochloride. The European Commission approved it in April 2014 under the brand name VOKANAMET.

The FDA cleared single agent canagliflozin, branded as INVOKANA, in March 2013.

Subscribe for full text news in your inbox