World of Pain for a Class of Drugs
Bextra is not approved in the U.S for any postsurgical care. Pfizer recently said it will conduct additional studies "to confirm the long-term cardiovascular safety profile" of Bextra for arthritis patients.
That other COX-2 drug, called Dynastat, is given intravenously and is a cousin of Bextra. Last month, Pfizer said it would submit an application to the FDA by year-end, or about six months later than the company originally had predicted. Dynastat is sold in 45 countries.
Another player in the COX-2 arena -- Novartis (NVS) -- has kept a low profile because its drug, Prexige, is still under review by the FDA. The drug has been approved in 21 countries.
Novartis submitted its application to the FDA in November 2002. But in September 2003, the FDA said Novartis had to provide additional test results. At the time, Novartis predicted it would take until 2005 for the drug to reach the U.S. market. More recently, but before Vioxx was pulled, Novartis predicted that Prexige would reach U.S. pharmacies in 2006.Late last month, Novartis withdrew its request for Prexige's approval in all European Union countries, pending a review of all COX-2 drugs by the EU counterpart of the FDA. Prexige has been approved by the U.K.
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