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FDA Rejects Pfizer Pain Drug
February 18, 2008

Regulators have rejected the application from Pfizer Inc. to market an injectable drug similar to its withdrawn Bextra arthritis pill, the company said yesterday.

The injectable medicine is in the same class of drugs as the Celebrex arthritis and pain pill from Pfizer and the Vioxx arthritis and pain pill from Merck. Vioxx was taken from the market last September after being shown to double the risk of heart attack and stroke after long-term use.

Pfizer, which continues to sell Celebrex, withdrew Bextra in Europe and the United States in April after regulators said its link to a sometimes-fatal skin condition, Stevens-Johnson syndrome, outweighed its benefits.

Pfizer said it disagreed with reasons given by the Food and Drug Administration for rejecting the injectable drug, whose chemical name is parecoxib.

The injectable drug is sold in the European Union and elsewhere overseas, mostly under the name Dynastat. European regulators have said benefits of that form of the drug, used to control pain after surgery, outweigh potential risks.




Website: http://www.nytimes.com/2005/09/21/business/21drug.html?_r=1&partner=rssnyt&emc=rss&oref=slogin

 
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