Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

Janssen’s Spravato Enters US Market With Enhanced REMS And Plans For A Monotherapy Trial

Executive Summary

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...



Last-Minute Pushback On Janssen’s EU Spravato Approval

What is in store for esketamine after third parties submit written interventions to the European Medicines Agency?

Keeping Track: US FDA, Industry Roar Into Fourth Quarter With Bevy Of Regulatory Announcements

The latest drug development news and highlights from our US FDA Performance Tracker.

J&J's Spravato's Star Power Rises While Zytiga's Sets

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. 

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

PS124879

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel