Axcan Helicide “not approvable”
Executive Summary
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...
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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.... |