PFIZER INC RECEIVES APPROVAL TO MARKET NEW ORAL COX-2 INHIBITOR BEXTRA (VALDECOXIB) IN EUROPE

Pfizer now offers the widest Cox-2 inhibitor portfolio

23-May-2003

Pfizer Inc has received approval to market Bextra® (valdecoxib) film coated tablets, the newest COX-2 selective inhibitor in its portfolio, in Europe for treatment of patients with pain and inflammation associated with osteoarthritis (OA), rheumatoid arthritis (RA) and primary dysmenorrhea (painful menstrual cramping).

Valdecoxib received marketing authorization from the European Commission with labelling that is valid in all 15 European Union (EU) member states, and the approval will be extended to Norway and Iceland. This approval allows Pfizer to offer the widest portfolio of COX-2 selective inhibitors in Europe.

"We are pleased with the EU Commission decision to approve Bextra and look forward to offering patients and physicians a new option for treating osteoarthritis, rheumatoid arthritis and primary dysmenorrhea", said Dr. Jack Watters, Pfizer's Vice President, Medical and Regulatory, Europe and Canada. "COX-2 selective inhibitors are an innovative class of medicines specifically developed to relieve pain and inflammation as effectively as widely used conventional non-steroidal anti-inflammatory drugs, while offering an improved upper gastrointestinal safety profile," he added.

Valdecoxib will be marketed under the brand names BEXTRA, VALDYN, and KUDEQ which will be used throughout the EU. Bextra was launched in the United States and Latin America in 2002 and is expected to become available in various countries within and outside of the EU this year.

Other products in Pfizer's COX-2 portfolio include CELEBREX® (celecoxib) which was approved in Europe through the mutual recognition process in 2000 for the symptomatic relief of osteoarthritis (OA) and rheumatoid arthritis (RA) and DYNASTAT® (parecoxib sodium for injection), which was granted marketing authorization in the EU in March 2002 for the short-term treatment of postoperative pain and has been launched in several markets in the Europe, Asia and Latin America.

https://www.chemeurope.com/en/news/23718/pfizer-inc-receives-approval-to-market-new-oral-cox-2-inhibitor-bextra-valdecoxib-in-europe.html