Axcan Helicide "not approvable" again
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
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...