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

Don’t Bogart That Labeling – Cesamet “Not Approvable”

This article was originally published in The Pink Sheet Daily

Executive Summary

Launch of Valeant’s cannabinoid agonist for chemotherapy-induced emesis, which had been marketed by Lilly before 2004, remains on hold as FDA seeks more information on adverse events.

You may also be interested in...



Cesamet Launch Will Highlight Longer Duration of Action Vs. Marinol

Valeant will also study the cannabinoid-receptor agonist in combination with other anti-emetics.

Cesamet Launch Will Highlight Longer Duration of Action Vs. Marinol

Valeant will also study the cannabinoid-receptor agonist in combination with other anti-emetics.

Valeant Cesamet Slated To Hit Market In “Next Several Weeks”

Approval comes with indication restricting use to patients who don’t respond to conventional antiemetics due to concern over “disturbing psychotomimetic reactions.”

Topics

UsernamePublicRestriction

Register

PS061462

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