Janssen’s Spravato Enters US Market With Enhanced REMS And Plans For A Monotherapy Trial
Restrictive risk management plan for antidepressant nasal spray requires patients be monitored for two hours after dosing and enroll in a patient registry; Janssen has agreed to conduct a monotherapy efficacy trial as a postmarketing commitment.
You may also be interested in...
What is in store for esketamine after third parties submit written interventions to the European Medicines Agency?
The latest drug development news and highlights from our US FDA Performance Tracker.
With Spravato's launch underway, J&J reports that 800 sites have been certified to administer the depression drug. Newer drugs drove pharma sales in the first quarter, while US sales of Zytiga declined 55% due to generic competition.