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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