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ADVISORY COMMISSION RECOMMENDS HALCION RETURN TO U.K. MARKET

 ADVISORY COMMISSION RECOMMENDS HALCION RETURN TO U.K. MARKET
 KALAMAZOO, Mich., July 20 /PRNewswire/ -- The Upjohn Company (NYSE: UPJ) has been informed that a government-appointed scientific advisory committee in the United Kingdom has recommended that Halcion Tablets should be returned to the market in that country. In a confidential report, the Medicines Commission has recommended that Halcion should be made available at a recommended dosage range from 0.125 mg to 0.25 mg. It said the dosage form should only be 0.125 mg tablets. Despite this advice, the U.K. Licensing Authority has proposed revocation of the product license for both 0.125 and 0.25 mg strengths of Halcion. Upjohn announced today that it will proceed with the appeal process.
 Upjohn has been appealing the Halcion suspension since it was instituted on Oct. 2, 1991. The Medicines Commission, which functions as the principal advisory committee on all aspects of the U.K. Medicines Act, was asked to undertake a complete review of Halcion safety data and heard a presentation by Upjohn researchers on May 15.
 Theodore Cooper, M.D., Ph.D., Upjohn chairman and chief executive officer, said, "We're encouraged by the opinion of the Medicines Commission regarding the 0.125 mg tablet; however, we also believe that the 0.25 tablet offers physicians and their patients an important treatment option. We will take all the steps we need to in order to get this product restored to patients and physicians in the United Kingdom."
 According to Professor Ian Hindmarch, head of psychopharmacology research at the Robens Institute in Surrey, the unavailability of Halcion in the U.K. for the past year has caused some physicians to prescribe older and less safe hypnotic products.
 Cooper said, "U.K. patients with sleep disorders have been deprived of a valuable medication for the past year. We hope for their sakes that this issue is resolved promptly."
 Following its May 18, 1992, meeting the U.S. Food And Drug Administration's Psychopharmacological Drug Products Advisory Committee concluded that Halcion is safe and effective when used as recommended. In the U.S., Upjohn introduced a patient package insert, revised labelling and a 10-tablet package last November in order to assure appropriate use of the product.
 Elsewhere in Europe, the European Community's Committee for Proprietary Medicinal Products (CPMP) last year recommended labelling and packaging changes for Halcion and is currently reviewing Halcion and other sleeping medications.
 In Canada, the Health Protection Branch announced in January of this year that a patient package insert and new packaging would also be implemented there.
 The Upjohn Company is a worldwide, research-based provider of human health care products, animal health products, agronomic and vegetable seeds and specialty chemicals. Headquartered in Kalamazoo, the company has been dedicated to improving health and nutrition for more than a century.
 -0- 7/20/92
 /CONTACT: Kaye Bennett of The Upjohn Company, 616-323-4224/
 (UPJ) CO: The Upjohn Company ST: Michigan IN: MTC SU:


SB -- DE013 -- 0685 07/20/92 11:17 EDT
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Publication:PR Newswire
Date:Jul 20, 1992
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