Zydus Lifesciences receives USFDA approval for Ibuprofen and Famotidine tablets, 800 mg/26.6 mg

Zydus Lifesciences has received final approval from the United States Food and Drug Administration (USFDA) to manufacture Ibuprofen and Famotidine tablets, 800 mg/26.6 mg. (USRLD: Duexis Tablets, 800 mg/26.6 mg).

Ibuprofen and famotidine combination is indicated for the relief of signs and symptoms of rheumatoid arthritis and osteoarthritis and to decrease the risk of developing upper gastrointestinal ulcers (gastric and/or duodenal ulcers), in patients who are taking ibuprofen for those indications.

Ibuprofen and famotidine tablets will be produced at Zydus Lifesciences (SEZ), Ahmedabad. Ibuprofen and Famotidine tablets had annual sales of USD 3.6 mn in the United States (IQVIA MAT December 2024).

 

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