Zydus Lifesciences secures USFDA nod for Ibuprofen, Famotidine Tablets for rheumatoid arthritis
Ahmedabad: Zydus Lifesciences Limited has announced that the Company 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 rheumatoidarthritis 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.
Rheumatoid arthritis (RA) is a chronic autoimmune disease that primarily affects the joints, causing pain, swelling, stiffness, and loss of function.
Ibuprofen and famotidine tablets will be produced at Zydus Lifesciences Ltd (SEZ), Ahmedabad.
Ibuprofen and Famotidine tablets had annual sales of USD 3.6 mn in the United States (IQVIA MAT December 2024). The group now has 415 approvals and has so far filed 483* ANDAs since the commencement of the filing process in FY 2003-04.
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Zydus Lifesciences Ltd. is an innovative, global lifesciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies. The group has a significant presence in cancer related therapies and offers a wide range of solutions with cytotoxic, supportive & targeted drugs.
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