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

Takeda's Rozerem Substance Abuse/Toxicity Claims Draw FDA Rebuke

This article was originally published in The Pink Sheet Daily

Executive Summary

The fact alone that Rozerem is not a controlled substance doesn't "confer added safety" or superiority, DDMAC says.

You may also be interested in...



Transcept Aims To Refile Intermezzo Insomnia NDA In Late Q4 With Highway Driving Data

FDA approved a resubmission plan that responds to concerns about inadvertent re-dosing and next-day driving impairment raised in an October "complete response" letter.

Transcept Aims To Refile Intermezzo Insomnia NDA In Late Q4 With Highway Driving Data

FDA approved a resubmission plan that responds to concerns about inadvertent re-dosing and next-day driving impairment raised in an October "complete response" letter.

Somaxon's Silenor Gains An FDA Approval, But Can The Pharma Afford A Launch?

Somaxon hopes to launch its insomnia drug in the second half of 2010, but is still searching for a U.S. commercial partner.

Topics

UsernamePublicRestriction

Register

LL1134531

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