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.
Read also: Zydus inks pact with Beihai Biotech for cancer drug Beizray commercialization in US
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.
Read also: Zydus Usnoflast gets USFDA Orphan Drug Designation for amyotrophic lateral sclerosis
Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.
NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.