Zydus Receives USFDA Nod For Celecoxib Capsules For Juvenile Rheumatoid Arthritis, Ankylosing Spondylitis

Zydus Lifesciences Limited, a pharma firm 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, the Ahmadabad based pharma firm said in a statement here recently.

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 now more commonly known as Juvenile Idiopathic Arthritis (JIA), is a chronic condition affecting children, with the onset typically occurring before the age of 16.

The disease is characterized by joint inflammation, pain, stiffness, and can also involve other symptoms like fever, rash, and eye inflammation. Importantly, JIA encompasses several subtypes, each with its own characteristics, and it can affect children of various ages, including those 2 years and older.

Another disease that these capsules are needed by the patients suffering with Ankylosing spondylitis (AS). It is a chronic inflammatory disease primarily affecting the spine and sacroiliac joints, leading to pain and stiffness. It can also affect other joints and organs, and in severe cases, can cause spinal fusion, resulting in a hunched posture. While there's no cure, treatments like medication, physical therapy, and exercise can manage symptoms and slow disease progression, say the doctors.

Celecoxib capsules will be produced at Zydus Lifesciences Ltd (SEZ), Ahmedabad.

With this approval, Zydus now has 428 product approvals from the USFDA. Since the company started filing Abbreviated New Drug Applications (ANDAs) in FY 2003–04, it has submitted a total of 492 ANDAs (as of March 31, 2025), said the statement.