Aurobindo Receives FDA Approval for Ibuprofen and Famotidine Tablets, 800 mg/26.6 mg
Published: June 30, 2025
East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application Ibuprofen and Famotidine Tablets, 800 mg/26.6 mg. Aurobindo Pharma’s Ibuprofen and Famotidine Tablets, are an AB-rated generic equivalent to the reference listed drug (RLD), Duexis® Tablets manufactured by Horizon Medicines LLC.
Ibuprofen and Famotidine Tablets are indicated for the:
- Relief of signs and symptoms of rheumatoid arthritis and osteoarthritis and to decrease the risk of developing upper gastrointestinal ulcers, which in the clinical trials was defined as a gastric and/or duodenal ulcer, in patients who are taking ibuprofen for those indications
