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 0rally disintegrating tablets, are an AB-rated generic equivalent to the reference listed drug (RLD), PREVACID SoluTab Delayed-Release Orally Disintegrating Tablets manufactured by Takeda Pharms USA, Inc.
Lansoprazole Delayed-Release Orally Disintegrating Tablets indicated for 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)
Lansoprazole Delayed-Release Orally Disintegrating Tablets has an estimated market size of US $32.8 Million for the twelve months ending January 2023, as per IQVIA.
