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...