European Commission Expands Labeling for Janssen’s Invokana and Vokanamet
The Janssen Pharmaceutical Companies of Johnson & Johnson announced that the European Commission (EC) has granted approval to update the Invokana (canagliflozin) and Vokanamet (canagliflozin and metformin) labelling to include changes to the indication statement for the treatment of adults with insufficiently controlled type 2 diabetes mellitus (T2DM) as an adjunct to diet and exercise. The decision…
Janssen Submits Nasal Spray New Drug Application to FDA for Depression
The Janssen Pharmaceutical Companies of Johnson & Johnson has submitted a New Drug Application (NDA) to the FDA for esketamine nasal spray. Janssen is seeking FDA approval of esketamine for treatment-resistant depression in adults. Esketamine is an investigational, rapidly acting antidepressant that works differently than currently available therapies for major depressive disorder. Through glutamate receptor modulation,…