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."


Explore further

Generic versions of plavix approved

More information: Full Article
More Information

Copyright © 2014 HealthDay. All rights reserved.

Citation: FDA approves generic version of celebrex (2014, June 3) retrieved 20 October 2020 from https://medicalxpress.com/news/2014-06-fda-version-celebrex.html
This document is subject to copyright. Apart from any fair dealing for the purpose of private study or research, no part may be reproduced without the written permission. The content is provided for information purposes only.
 shares

Feedback to editors

User comments