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

UsernamePublicRestriction
UsernamePublicRestriction

Bristol-Myers Squibb UFT

Executive Summary

Oral colorectal cancer therapy receives "not approvable" letter from FDA March 23. The NDA for uracil/tegafur for the treatment of advanced colorectal cancer was resubmitted April 20, 2000 after being withdrawn March 17, 2000. FDA's Oncologic Drugs Advisory Committee recommended UFT for approval in September 1999 following analysis of the contribution of uracil. A 1,500-patient cooperative study for the adjuvant treatment of colorectal cancer is expected to complete in 2002
Advertisement

Related Content

Oncology Indications Can Be Cellular Targets Rather Than Organs, FDA Says
Oncology Indications Can Be Cellular Targets Rather Than Organs, FDA Says
House Committee Watching Genasense; Show Of Force During FDA Review
House Committee Watching Genasense; Show Of Force During FDA Review
FDA GI Division Director Justice Is Returning To FDA From Genentech
FDA GI Division Director Justice Is Returning To FDA From Genentech
Bristol-Myers Squibb UFT
Bristol-Myers Squibb UFT
UFT
UFT
Advertisement
UsernamePublicRestriction

Register

PS037576

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