FDA approves generic version of celebrex

FDA approves generic version of celebrex

(HealthDay)—The U.S. Food and Drug Administration on Friday gave its approval to the first generic version of the pain reliever Celebrex (celecoxib).

On Friday, Teva Pharmaceutical Industries got the nod from the FDA to market of celecoxib capsules in 50 mg, 100 mg, 200 mg, and 400 mg strengths. Mylan Pharmaceuticals Inc. received permission to market 50 mg celecoxib capsules, the agency said.

According to the FDA, like all nonsteroidal anti-inflammatory drug (NSAID) medications, generic celecoxib will "have a Boxed Warning in their prescribing information (label) to alert and patients about the risk of heart attack or stroke that can lead to death. This chance increases for people with heart disease or risk factors for it, such as , or taking NSAIDs for long periods of time."

"It is important for patients to have access to affordable treatment options for chronic conditions," Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research, said in an agency statement. "Health care professionals and patients can be assured that these FDA-approved generic drugs have met our rigorous approval standards."

More information: Full Article
More Information

add to favorites email to friend print save as pdf

Related Stories

Generic versions of plavix approved

May 18, 2012

(HealthDay) -- The first generic versions of Plavix (clopidogrel bisulfate) have been approved by the U.S. Food and Drug Administration.

Generic aciphex approved to treat chronic heartburn

Nov 08, 2013

(HealthDay)—The first generic versions of the anti-GERD drug Aciphex (rabeprazole sodium) have been approved by the U.S. Food and Drug Administration for people aged 12 and older, the agency said Friday.

Pfizer painkiller gets longer patent protection (Update)

Mar 05, 2013

Drugmaker Pfizer Inc. said Tuesday that a new patent on one of its top drugs, anti-inflammatory painkiller Celebrex, extends its U.S. patent protection by 18 months, potentially bringing the company a few billion dollars ...

Daily aspirin regimen not safe for everyone, FDA warns

May 06, 2014

(HealthDay)—Taking an aspirin a day can help prevent heart attack and stroke in people who have suffered such health crises in the past, but not in people who have never had heart problems, according to ...

Recommended for you

Most US babies get their vaccines, CDC says

4 hours ago

(HealthDay)—The vast majority of American babies are getting the vaccines they need to protect them from serious illnesses, federal health officials said Thursday.

Expression of privilege in vaccine refusal

Aug 27, 2014

Not all students returning to school this month will be up to date on their vaccinations. A new study conducted by Jennifer Reich, a researcher at the University of Colorado Denver, shows that the reasons why children may ...

User comments