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Aurobindo Receives FDA Approval for Lansoprazole Delayed-Release Orally Disintegrating Tablets, 15mg and 30mg   

Published: March 29, 2023

East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application Lansoprazole Delayed-Release Orally Disintegrating Tablets, 15 mg and 30 mg. Aurobindo Pharma’s Lansoprazole Delayed-Release Orally Disintegrating Tablets, are an AB-rated generic equivalent to the reference listed drug (RLD), PREVACID® SoluTabTM Delayed-Release Orally Disintegrating Tablets manufactured by Takeda Pharms USA, Inc.

Lansoprazole Delayed-Release Orally Disintegrating Tablets are indicated for the following:

  • Short-Term Treatment of Active Duodenal Ulcer.
  • H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence.
  • Maintenance of Healed Duodenal Ulcers.
  • Short-Term Treatment of Active Benign Gastric Ulcer.
  • Healing of nonsteroidal anti-inflammatory drugs (NSAID)- Associated Gastric Ulcer.
  • Risk Reduction of NSAID-Associated Gastric Ulcer.
  • Gastroesophageal Reflux Disease (GERD).
  • Maintenance of Healing of Erosive Esophagitis (EE).
  • Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome (ZES).