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

Anesta Actiq

Executive Summary

Company files amendment to NDA May 4 for oral transmucosal fentanyl citrate in the treatment of chronic pain. The amendment contains a reanalysis of the adverse events and dosing profiles data, more information on stability and packaging, and an expansion and clarification of Anesta's proposed risk-management plan. Anesta received a "not approvable" letter in November for the NDA submitted a year earlier ("The Pink Sheet" Nov. 24, 1997, T&G-11)
Advertisement
Advertisement
UsernamePublicRestriction

Register

PS032131

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