Zydus Lifesciences bags USFDA okay for Celecoxib Capsules for juvenile rheumatoid arthritis treatment in children
Celecoxib capsules will be produced at Zydus Lifesciences Ltd (SEZ), Ahmedabad.
Ahmedabad: Zydus Lifesciences Limited has received final approval from the United States Food and Drug Administration (USFDA) for Celecoxib Capsules, 50 mg, 100 mg, 200 mg, and 400 mg (USRLD: Celebrex Capsules, 50 mg, 100 mg, 200 mg, and 400 mg).
Celecoxib is a nonsteroidal anti-inflammatory drug (NSAID). It works by reducing hormones that cause inflammation and pain in the body. It is used to treat pain or inflammation caused by many conditions such as arthritis, ankylosing spondylitis, and menstrual pain. It is also used to treat juvenile rheumatoid arthritis in children who are at least 2 years old.
Celecoxib capsules will be produced at Zydus Lifesciences Ltd (SEZ), Ahmedabad. Celecoxib capsules had annual sales of USD 122.6 mn in the United States (IQVIA MAT May 2025)
The group now has 428 approvals and has so far filed 492 ANDAs since the commencement of the filing process in FY 2003-04.
Earlier this year in February, the Company also received USFDA approval 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.
Read also: Zydus Lifesciences secures USFDA nod for Ibuprofen, Famotidine Tablets for rheumatoid arthritis
Zydus Lifesciences Ltd. is an innovative, global lifesciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies. The group employs 27,000 people worldwide, including 1,400 scientists engaged in R & D. Over the last decade, Zydus has introduced several innovative, first-in-class products in the market for treating unmet healthcare needs with vaccines, therapeutics, biologicals and biosimilars.
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