Pylera Approval History
- FDA approved: Yes (First approved September 28th, 2006)
- Brand name: Pylera
- Generic name: bismuth subcitrate potassium, metronidazole and tetracycline
- Previous name: Helizide
- Company: Axcan Pharma Inc.
- Treatment for: Helicobacter Pylori Infection
Pylera (bismuth subcitrate potassium, metronidazole and tetracycline) is a 3-in-1 capsule triple therapy indicated for the eradication of Helicobacter pylori, a bacterium now recognized as being the main cause of gastric and duodenal ulcers.
Development History and FDA Approval Process for Pylera
|Sep 28, 2006||Pylera Axcan Pharma Inc. - Treatment for Eradication of Helicobacter pylori|
|Mar 29, 2006||Axcan submits FDA amendment to its new drug application for Helizide|
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