☀️     🌓

Prescribing Advice for GPs

An NHS Prescribing Advisers' Blog

FDA reject etoricoxib for OA

The Food and Drugs Administration (FDA) has issued a Non Approvable Letter for etoricoxib (Arcoxia®) in osteoarthritis (OA) according to the manufacturer's website.

Etoricoxib is a Cox-II selective non-steroidal anti-inflammatory that is available and licensed in the UK for osteoarthritis, rheumatoid arthritis and gout. The FDA rejected the application for a licence in OA and requested additional data in support of the benefit-to-risk profile.

Action: Etoricoxib is licensed for OA in the UK, however it may be prudent to restrict use of this drug in OA based on the cautious approach taken in America.

Share 'FDA reject etoricoxib for OA' by emailShare 'FDA reject etoricoxib for OA' on FacebookShare 'FDA reject etoricoxib for OA' on TwitterShare 'FDA reject etoricoxib for OA' on LinkedInShare 'FDA reject etoricoxib for OA' on reddit


No Comments to “FDA reject etoricoxib for OA”

Leave a Comment

Your email address will not be published. Required fields are marked *

Please be aware that you comment is subject to our Privacy Policy.

This site uses Akismet to reduce spam. Learn how your comment data is processed.

Prescribing Advice for GPs is powered by ClassicPress.
Connect to our RSS or Atom Feeds.