FDA Approved: PROTONIX DELAYED-RELEASE — Supplemental Application (Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.)

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Summary

FDA approved a supplemental application for Protonix Delayed-Release (pantoprazole sodium) from Wyeth/Pfizer to modify/expand its labeling.

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Diseases / indications

• Duodenal Ulcer
• Erosive Esophagitis
• Gastric Ulcer
• Gastroesophageal Reflux Disease
• Peptic Ulcer Disease
• Zollinger-ellison Syndrome

Drugs mentioned

• PROTONIX DELAYED-RELEASE (Pantoprazole sodium)

Snippet

SUPPL AP for PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM)