Generic Celebrex Approved!

Roni Shye
Roni Shye, PharmD BCGP BCACP, is a licensed pharmacist in the states of Florida, Ohio, and Pennsylvania.
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Generic Celebrex (celecoxib) has been approved by the FDA as of May 30, 2014. Teva Pharmaceuticals received exclusive market rights for 180 days on the 100 mg, 200 mg, and 400 mg capsules, while Mylan Pharmaceuticals has also been approved to market the 50 mg capsules.

When will generic celecoxib be available?

Mylan Pharmaceuticals plans to begin selling their 50 mg capsule at the earliest point it can, but not later than December 2014. Teva Pharmaceuticals, however, has not disclosed when it will bring their generic to the market.

What is celecoxib?
Celecoxib (Celebrex) is a nonsteroidal anti-inflammatory (NSAID) indicated for the treatment of rheumatoid arthritis, osteoarthritis, short-term pain, and ankylosing spondylitis.

What’s special about celecoxib?
Celecoxib is considered a selective COX-1 inhibitor. Basically, what that means is celecoxib, unlike some other non-steroidal anti-inflammatory medications, was created to be easier on the stomach.

What is the black box warning associated with Celebrex (celecoxib)?
Celebrex (celecoxib) has a black box warning for cardiovascular events such as heart attack or stroke and stomach bleeding/ulcer. This warning indicates that there is a reasonable amount of evidence associated with the medication and these possible side effects.

How is celecoxib taken?
Celecoxib is available as a capsule in the following strengths: 50 mg, 100 mg, 200 mg, and 400 mg. Depending on the condition, it is often taken as 100 mg to 200 mg per day (in one or two doses per day), though your doctor will prescribe the best dose for you.

What are some of the common side effects?

The common side effects of celecoxib include stomach pain, diarrhea, indigestion, gas, swelling of feet/legs, accidental injury, dizziness, inflammation of the throat, runny nose, swollen nasal passages, upper respiratory infection, and rash.

Check out the FDA approval here.

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