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

Lexapro "not approvable" again

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Forest has not yet decided on a course of action following a second "not approvable" letter for use of Lexapro (escitalopram) in panic disorder, but is not planning to conduct additional studies at this time, the firm says March 1. FDA's initial "not approvable" letter in February 2004 "raised issues related to methods and statistical analyses performed for the two placebo-controlled studies provided in the submission," the firm said. Forest's separate sNDA for social anxiety disorder has a user fee date of March 25...
Advertisement

Related Content

Topics

Advertisement
UsernamePublicRestriction

Register

PS002829

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