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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, 2006Approval Pylera Axcan Pharma Inc. - Treatment for Eradication of Helicobacter pylori
Mar 29, 2006Axcan submits FDA amendment to its new drug application for Helizide

Further information

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