Pink Sheet is part of the Business Intelligence Division 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


Forest COPD Combo Hits Roadblock En Route To NDA Filing

This article was originally published in The Pink Sheet Daily

Executive Summary

Forest is delaying submission of an NDA for aclidinium/formoterol to resolve FDA concerns about the formulation’s chemistry, manufacturing and control specifications.


Related Content

Forest’s LABA/LAMA Delay Gives GSK A Lengthy Lead On The Market
COPD Market Snapshot: New Products, Limited Differentiation
Forest Tudorza Pressair Approval For COPD Includes Post-marketing CV Safety Study
Forest Admits To Knowingly Obstructing FDA Inspection In Guilty Pleas On Levothroid, Celexa Marketing


Related Companies




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