Pylera FDA Approval History
FDA Approved: Yes (First approved September 28, 2006)
Brand name: Pylera
Generic name: bismuth subcitrate potassium, metronidazole and tetracycline
Dosage form: Capsules
Previous Name: Helizide
Company: Allergan plc
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 Timeline for Pylera
|Sep 28, 2006||Approval 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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