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).