NEW YORK, Sept. 20 /PRNewswire-FirstCall/ -- Pfizer Inc said today it
disagrees with the conclusions stated in a non-approvable letter it received
from the U.S. Food and Drug Administration regarding parecoxib sodium, a non-
narcotic injectable COX-2 selective analgesic for the treatment of acute pain.
The company plans to meet with the FDA to discuss the agency's concerns.
Pfizer said parecoxib is widely available worldwide, including in the
European Union, mostly under the brand name Dynastat.
As the only injectable COX-2 specific inhibitor, Dynastat provides
physicians and patients with an important option in the treatment of acute
pain in the post-surgical setting. Administered for short periods of time
under the supervision of a healthcare professional, Dynastat has been shown to
reduce the need for opioids to control pain following surgery.
Earlier this year the COX-2 class of pain medicines underwent an extensive
review by the European Medicines Evaluation Agency. The agency concluded that,
based on the overall safety data and with appropriate labeling, "the benefits
(of Dynastat) continue to outweigh the risks." Further, many other regulatory
agencies worldwide conducted similar reviews and arrived at a similar
conclusion.
SOURCE Pfizer Inc
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CONTACT:
Mariann Caprino, of Pfizer Inc,
+1-212-733-4554
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