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

Approvals In Brief

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Takeda's Rozerem sleep aid to debut in September: Insomnia agent Rozerem (ramelteon) will launch in September after receiving FDA approval July 22, Takeda says. Indicated for "treatment of insomnia characterized by difficulty with sleep onset," Rozerem will be marketed by more than 1,000 reps highlighting its melatonin receptor activity and lack of abuse potential, the company says. Rozerem is the first MT-1/MT-2 melotonin agonist approved for insomnia. The leading insomnia therapies - Sanofi-Aventis' Ambien (zolpidem), Sepracor's Lunesta (eszopiclone) and King's Sonata (zaleplon) - target the gamma-aminobutyric acid receptor complex. Takeda notes that Rozerem is unique in that "all other prescription medications indicated for insomnia are classified as Schedule IV controlled substances" by the Drug Enforcement Administration (1Pharmaceutical Approvals Monthly February 2005, p. 10)...

You may also be interested in...



Takeda Ramelteon Sales Force Size Depends On Competitor Detailing

FDA Priority Review Voucher Redemption Fee Set At $4.6 Million In FY 2011

Redeeming a priority review voucher obtained by developing a drug for a tropical disease will cost companies $6.1 million in fiscal 2011

September 2010 Approvals

Product

Topics

UsernamePublicRestriction

Register

OM014079

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