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

Lercanidipine "Approvable"; COHORT Shows Edema Advantage Over Norvasc

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Forest is highlighting a lower rate of edema as a potential tolerability advantage for its antihypertensive lercanidipine, based on results from the European COHORT trial.

You may also be interested in...



Campral Approved On Re-Audit, FDA Backs Off Additional Study Request

Forest/Lipha Campral additional clinical trial was not necessary because problems with the original data dealt with handling, not reliability, review documents show. FDA allowed Lipha to conduct a re-audit of three pivotal non-U.S. trials to support approval of the alcoholism treatment. Agency originally requested a new U.S. pivotal trial after deeming the NDA’s original U.S. pivotal "truly a failed study." Issues of concern were "sloppy" data collection, poorly or non-defined primary endpoints, and the potential for multiplicity upon re-analysis of old data

FDA Priority Review Voucher Redemption Fee Set At $4.6 Million In FY 2011

Redeeming a priority review voucher obtained by developing a drug for a tropical disease will cost companies $6.1 million in fiscal 2011

September 2010 Approvals

Product

Topics

UsernamePublicRestriction

Register

OM013658

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