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Axcan Helicide, Photofrin Barrett’s Approvals Expected By Year-End

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Axcan plans to position its Helicobacter pylori treatment Helicide as more effective than a clarithromycin-based regimen in antibiotic-resistant patients.

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Axcan Helicide "not approvable" again

Axcan receives second "not approvable" letter for its H. pylori agent Helicide (bismuth/metronidazole/tetracycline) Oct. 3, citing ongoing manufacturing deficiencies at one of five manufacturing sites. Axcan received the first not approvable letter Aug. 12, 2002 addressing similar manufacturing-related issues. The firm said it "will meet with FDA in the coming weeks to discuss alternative plans." The Canadian firm previously projected approval before year-end (1Pharmaceutical Approvals Monthly May 1, 2003, p. 10). Helicide was approved in Canada March 14...

Axcan Helicide "not approvable" again

Axcan receives second "not approvable" letter for its H. pylori agent Helicide (bismuth/metronidazole/tetracycline) Oct. 3, citing ongoing manufacturing deficiencies at one of five manufacturing sites. Axcan received the first not approvable letter Aug. 12, 2002 addressing similar manufacturing-related issues. The firm said it "will meet with FDA in the coming weeks to discuss alternative plans." The Canadian firm previously projected approval before year-end (1Pharmaceutical Approvals Monthly May 1, 2003, p. 10). Helicide was approved in Canada March 14...

Axcan Helicide amendment

Axcan submits Helicide amendment addressing manufacturing issues in response to "not approvable" letter from FDA, announced in August. An NDA for the H. pylori eradication agent (subcitrate/metronidazole/tetracycline) was submitted Sept. 30, 200

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