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US spurns injectable Pfizer drug similar to Bextra

Posted on: Tuesday, 20 September 2005, 10:35 CDT

CHICAGO (Reuters) - U.S. regulators have rejected Pfizer Inc.'s application to market an injectable drug very similar to its withdrawn Bextra arthritis pill, the company said on Tuesday.

The injectable medicine is in the same class of drugs as Pfizer's Celebrex arthritis and pain pill and Merck and Co.'s Vioxx arthritis and pain pill. Vioxx was pulled off 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, pulled Bextra pills off the market in Europe and the United States in April after regulators said its link to a sometimes fatal skin condition, Stevens-Johnson Syndrome, outweighed the drug's benefits. Bextra had sales last year of $1.3 billion.

Pfizer said it disagrees with reasons given by the U.S. Food and Drug Administration for rejecting the injectable drug, whose chemical name is parecoxib. The New York-based drugmaker said it plans to meet with FDA officials to discuss the agency's concerns.

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

Shares of Pfizer were unchanged at $25.60 in morning trade on the New York Stock Exchange.

(Additional reporting by Ransdell Pierson in New York)

Source: REUTERS

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