FDA approves generic version of celebrex

June 3, 2014
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."

Explore further: Generic versions of plavix approved

More information: Full Article
More Information

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

November 8, 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.

US approves India's Ranbaxy to make generic Lipitor

December 1, 2011
Indian pharmaceutical giant Ranbaxy won US regulatory approval to make the first generic version of cholesterol lowering drug Lipitor, a Pfizer product whose patent expired Wednesday.

Pfizer painkiller gets longer patent protection (Update)

March 5, 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 6, 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 the U.S. Food and ...

FDA approves first generic versions of Cymbalta

December 11, 2013
The Food and Drug Administration says it has approved the first generic versions of the blockbuster antidepressant drug Cymbalta, offering lower-cost access to one of the most widely prescribed treatments for depression, ...

Recommended for you

In most surgery patients, length of opioid prescription, number of refills spell highest risk for misuse

January 17, 2018
The possible link between physicians' opioid prescription patterns and subsequent abuse has occupied the attention of a nation in the throes of an opioid crisis looking for ways to stem what experts have dubbed an epidemic. ...

Patients receive most opioids at the doctor's office, not the ER

January 16, 2018
Around the country, state legislatures and hospitals have tightened emergency room prescribing guidelines for opioids to curb the addiction epidemic, but a new USC study shows that approach diverts attention from the main ...

FDA bans use of opioid-containing cough meds by kids

January 12, 2018
(HealthDay)—Trying to put a dent in the ongoing opioid addiction crisis, the U.S. Food and Drug Administration on Thursday slapped strict new restrictions on the use of opioid-containing cold and cough products by kids.

Taking ibuprofen for long periods found to alter human testicular physiology

January 9, 2018
A team of researchers from Denmark and France has found that taking regular doses of the pain reliever ibuprofen over a long period of time can lead to a disorder in men called compensated hypogonadism. In their paper published ...

Nearly one-third of Canadians have used opioids: study

January 9, 2018
Nearly one in three Canadians (29 percent) have used "some form of opioids" in the past five years, according to data released Tuesday as widespread fentanyl overdoses continue to kill.

Growing opioid epidemic forcing more children into foster care

January 8, 2018
The opioid epidemic has become so severe it's considered a national public health emergency. Addiction to prescription painkillers, such as oxycodone and morphine, has contributed to a dramatic rise in overdose deaths and ...

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.