J&J Seeks A Priority Review For Depression Drug Esketamine
Janssen filed an NDA for esketamine nasal spray for treatment-resistant depression with FDA, which could grant a six-month priority review.
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Datamonitor projects the newly US FDA-approved esketamine product for treatment-resistant depression will reach sales of almost $2bn in the US, Japan and five major European markets.
Keeping Track: J&J Esketamine, Sanofi Caplacizumab Lead Off September Submissions; US FDA Says No To Nucala
The latest drug development news and highlights from our US FDA Performance Tracker.
Around three dozen key late-stage products could reach their first markets in 2019, according to a recent report from Informa Pharma's Biomedtracker. Company execs may need to plan for the disruptive potential of this group of new medicines on established markets and standards of care.