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.

Menu

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
My View
Tags:
BioPharmaceutical

Somaxon To Conduct Preclinical Tests On Its Phase III Insomnia Drug Silenor

This article was originally published in The Pink Sheet Daily

  • News

Executive Summary

FDA has requested that preclinical studies on low-dose doxepin be included in the 505(b)(2) application.

You may also be interested in...



Silenor’s Bleary Regulatory Timeline May Clear Up

Somaxon’s sleep aid is on track for a third-quarter NDA submission; partnering deal also expected during 2007.

Silenor’s Bleary Regulatory Timeline May Clear Up

Somaxon’s sleep aid is on track for a third-quarter NDA submission; partnering deal also expected during 2007.

Somaxon To Put Silenor Phase III Program To Bed In December

Firm's Q3 2007 filing timeframe puts it ahead of Neurocrine's resubmission plans for immediate-release indiplon.

Table

View full table

Topics

Tags:
BioPharmaceutical
Latest Headlines

CDER, CBER Not Seeing Hiring Slowdown Despite US FDA Warnings

Medicare Reimbursement For Part B Drugs Is 48% Above 340B Prices To Hospitals, MedPAC Finds

Drug Shortages, Inspections In Focus At US FDA Appropriations Hearing

Global Pharma Guidance Tracker – March 2024

See All
UsernamePublicRestriction

Register

PS064537

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

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