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FDA PANEL SAYS THAT STUDIES SUPPORT SAFETY AND EFFICACY OF REACTINE(R), PFIZER'S ANTIHISTAMINE

 NEW YORK, April 27 /PRNewswire/ -- Pfizer Inc (NYSE: PFE) said today that the Pulmonary-Allergy Drugs Advisory Committee concluded that there were sufficient adequate and well-controlled studies to support the safety and efficacy of the oral antihistamine Reactine (cetirizine). Pfizer filed a New Drug Application (NDA) with the Food and Drug Administration for the anti-allergy drug in July 1988.
 The consensus of the advisory panel was that there was sufficient data to support the following three indications Pfizer had sought: seasonal allergic rhinitis (allergies caused by pollen); perennial allergic rhinitis (year-round allergies); and urticaria (hives and itching). If approved by the FDA, this would permit Reactine to be prescribed to a larger patient population than any other recently approved antihistamine.
 The advisory committee agreed that cardiovascular safety of Reactine is supported by the available data. Pfizer noted that Reactine differs from currently available second-generation antihistamines because it is excreted primarily through the kidneys, thereby minimizing the potential for undesirable interaction with hepatically metabolized antibiotics and anti-fungal drugs.
 Clinical studies submitted in support of the NDA, show that Reactine at 5 and 10 mg. doses, caused a low incidence of sedation as compared to placebo, but performance, as measured in objective tests was not impaired. The advisory committee recommended to the FDA that the distinctions between Reactine and the first generation antihistamines be described further.
 The advisory committee is a panel of independent scientists whose recommendation will now be considered by FDA. On approval, Reactine will be marketed by Pfizer Labs; it will be available in 5 and 10 mg. tablets, taken once-a-day with or without food.
 Pfizer Inc is a diversified, research-based health care company with global operations. The company reported sales of approximately $7.23 billion for 1992.
 -0- 4/27/93
 /CONTACT: A. A. Biesada, 212-573-2055, or Rick Honey, 212-573-2051, for Pfizer Inc/
 (PFE)


CO: Pfizer Inc ST: New York IN: MTC SU:

LD -- NY127 -- 1684 04/27/93 18:08 EDT
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Date:Apr 27, 1993
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