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Pylera Approval History

  • FDA approved: Yes (First approved September 28th, 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 History and FDA Approval Process 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

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