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

FDA Holds To High Standards For Insomnia Drugs With Second “Complete Response” For Transcept’s Intermezzo

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

FDA’s second “complete response” letter for Transcept Pharmaceuticals’s Intermezzo continues the strict scrutiny the agency has given recent candidates for sleep maintenance insomnia indications.

You may also be interested in...



Obesity Drugs Go Back To The Drawing Board; FDA To Hold Advisory Committee On CV Risk

FDA will conduct an advisory committee early in 2012 to discuss how to assess the cardiovascular risk of weight-loss drugs, Orexigen revealed June 3 in announcing the firm will halt development in the U.S. of its obesity medication Contrave.

Transcept's NDA Intermission For Insomnia Drug Intermezzo Set To End In First Quarter

Results from a driving impairment study strengthen the case for approval, the company says.

Somaxon Sleep Aid Silenor Not Effective, FDA Says

In its second "complete response" letter for the chronic insomnia drug, FDA says Silenor fails to meet approval standards.

Topics

UsernamePublicRestriction

Register

PS004783

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