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

Axcan Helicide “not approvable”

Executive Summary

FDA deems Axcan's H. pylori treatment Helicide (bismuth/metronidazole/tetracycline) "not approvable" due to its manufacturer's inability to implement corrective actions with regard to production of bismuth, company says Oct. 6. Axcan had previously received a "not approvable" letter because of manufacturing (1"The Pink Sheet" Aug. 19, 2002, In Brief). Axcan will meet with FDA in the coming weeks to discuss plans to switch manufacturers...
Advertisement

Related Content

Advertisement
UsernamePublicRestriction

Register

PS042598

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