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

Merck’s Suvorexant Driving Claims May Get Green Light After Lunesta Re-Label

This article was originally published in The Pink Sheet Daily

Executive Summary

FDA signals comfort with declaring low dose of at least one insomnia product as OK for next-day driving, but suvorexant’s fate will depend on Merck’s data.

You may also be interested in...



Insomnia Drug Development Programs Must Include Driving Studies, FDA Says

Agency will require driving simulation studies for all new sleep aids and is asking sponsors of currently approved products to conduct such trials. FDA is directing zolpidem-containing product manufacturers to make labeling changes based, in part, on driving data submitted for Transcept’s Intermezzo.

Transcept Gains Long-Delayed Approval Of Intermezzo

Indication for insomnia characterized by middle-of-the-night awakening followed by difficulty returning to sleep is a first.

FDA's Emergency Use Authorization for Malaria Drugs Could Hinder Trials of Other COVID-19 Treatments

Questions linger about the role the White House played in pushing the EUA, which comes with large product donations from Bayer and Sandoz that are expected to alleviate supply chain pressures for the drugs. 

Topics

Related Companies

UsernamePublicRestriction

Register

PS077222

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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