FDA Approves Generic Version of Celebrex

The U.S. Food and Drug Administration (FDA) has approved a generic version of Pfizer‘s Celebrex (celecoxib), an oral medication used to treat inflammation and pain caused by ankylosing spondylitis and other disorders.

The new generic is made by the India-based company Unichem Laboratories, which announced the approval of its abbreviated new drug application (required by the FDA for consideration of a generic medication) in a press release. Unichem’s celecoxib capsules will be available in four different doses: 50 mg, 100 mg, 200 mg, and 400 mg.

Celebrex’s recommended dosing for ankylosing spondylitis under its FDA label is 200 mg once a day, or 100 mg twice daily. It was first approved in the U.S. in 1998.

In addition, the generic is indicated to treat osteoarthritis, rheumatoid arthritis, juvenile arthritis, acute pain, and primary dysmenorrhea (pain caused by menstruation).

Generic medicines contain the same active ingredient, and are created to have the same efficacy, safety, and route of administration as brand-name therapies, but are made by a different manufacturer. Because they can introduce increased competition into the market and do not need the extensive testing of an entirely new medication, generics are often less expensive than their brand-name counterparts.

Celecoxib is a non-steroidal anti-inflammatory drug (NSAID). Over-the-counter NSAIDs include medications such as high-dose aspirin and ibuprofen — sold as Advil and Motrin, among others brands. Celebrex and other NSAIDs are indicated for the treatment of pain caused by arthritis and other  conditions.

Celecoxib primarily works by blocking the activity of cyclooxygenase 2 (COX-2). After infection or injury, this enzyme helps to release prostaglandins, which are lipid (fat) molecules that can drive inflammation. As such, by blocking COX-2, celecoxib is designed lessen inflammation and pain.

Other NSAIDs target both COX-2 and COX-1 at therapeutic doses. Being a selective COX-2 inhibitor means that celecoxib may lead to less adverse gastrointestinal side effects than treatments that bind to both COX enzymes.

Similar to other NSAIDs, Celebrex’s FDA label carries a warning that it may increase the risk of cardiovascular adverse events, such as heart attack and stroke. Its label also notes a possibility of gastrointestinal effects, such as intestinal bleeding and ulcers, particularly in the elderly or in those with a prior history of peptic ulcer disease — painful sores or ulcers in the lining of the stomach or the first part of the small intestine — and/or of gastrointestinal bleeding.