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Biotech / Medical : Pharma News Only (pfe,mrk,wla, sgp, ahp, bmy, lly)

PFE 25.71

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3:59 PM EST

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To: Anthony Wong who wrote (362)	6/19/1998 3:21:00 PM
From: Anthony Wong	Read Replies (1) of 1722

Pfizer Receives Non-Approvable Letter From FDA for the ntipsychotic Zeldox Friday June 19, 2:45 pm Eastern Time Company Press Release SOURCE: Pfizer Inc NEW YORK, June 19 /PRNewswire/ -- Pfizer Inc (NYSE: PFE - news) said today it has received a non-approvable letter from the U.S. Food and Drug Administration for its novel antipsychotic Zeldox (ziprasidone Hcl). Pfizer said it is planning to meet with the FDA to discuss the issues raised by the agency, including the possible submission of additional data, as suggested by the FDA. ''We are obviously disappointed at this development, but remain confident of the safety and efficacy of Zeldox,'' said John F. Niblack, Ph.D., executive vice president of Pfizer Inc and head of Research and Development. ''We remain committed to making every effort to bring this medicine to patients in the U.S. and around the world. ''We believe that the additional studies and analyses suggested by the FDA can be undertaken in a relatively short period, and that we will be able to advance the application accordingly,'' said Dr. Niblack. SOURCE: Pfizer Inc biz.yahoo.com

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