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...
You may also be interested in...
Axcan Helicide “not approvable”
Axcan's Helicobacter pylori treatment Helicide (subcitrate/metronidazole/tetracycline) is deemed "not approvable" by FDA, company says Aug. 13. FDA's decision is based on a change in manufacturing sites by one of its European raw material suppliers for the drug, Axcan says; FDA will inspect the new facility after Axcan submits its response to FDA, expected by Oct. 30. The company still plans to launch the product by early 2004...
Cosmetic And Personal Care Trademark Review: 16 April
Personal care and cosmetic product trademark filings compiled from the Official Gazette of the US Patent and Trademark Office, Class 3.
Health And Wellness Weekly Trademarks Review: 16 April
Trademarks are registered and published for opposition with the US Patent and Trademark Office and are published weekly in the agency's Official Gazette.