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

Pfizer/Neurocrine File First Indiplon NDA With Eye On Fourth Quarter 2005 Launch

This article was originally published in The Pink Sheet Daily

Executive Summary

Filing for immediate-release formulation of insomnia agent will be followed by extended-release submission in November, Neurocrine says. A simultaneous launch is planned. Firms are highlighting long-term use, middle-of-the-night dosing.

You may also be interested in...



Takeda’s Sleep Aid Rozerem Could Avoid Controlled Substance Scheduling, Firm Says

The insomnia agent ramelteon uses a different mechanism of action than Sanofi-Aventis’ Ambien and Sepracor’s Lunesta, both of which are Schedule IV substances. Rozerem NDA is pending at FDA with a July 22 user fee date.

Takeda’s Sleep Aid Rozerem Could Avoid Controlled Substance Scheduling, Firm Says

The insomnia agent ramelteon uses a different mechanism of action than Sanofi-Aventis’ Ambien and Sepracor’s Lunesta, both of which are Schedule IV substances. Rozerem NDA is pending at FDA with a July 22 user fee date.

Sanofi-Aventis Eyes Summer Launch For Ambien CR

Discussions with FDA following an "approvable" letter for the sleep therapy have revolved around labeling for treatment duration, the company says. A summer launch would put Ambien CR's introduction several months behind that of Sepracor's Lunesta, which entered the insomnia market in early April.

Related Content

Topics

UsernamePublicRestriction

Register

ID1132115

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