Regulators spurn injectable Pfizer drug

CHICAGO (Reuters) – Regulators have rejected Pfizer’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withdrawn Bextra arthritis pill, the company said on Tuesday.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)