Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

Transcept Gains Long-Delayed Approval Of Intermezzo

This article was originally published in The Pink Sheet Daily

Executive Summary

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

You may also be interested in...



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

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.

Gender-Based Dosing For Insomnia Drugs Dissected In NEJM

CDER officials explain the rationale behind new labeling on zolpidem-containing immediate- and controlled-release products that halves the recommended dose for women. Labeling changes include a new precaution against next-day driving following use of Sanofi’s Ambien CR.

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.

Related Content

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS073089

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