Printer Friendly

UPJOHN ANNOUNCES NEW U.S. PACKAGING AND LABELING FOR HALCION

      UPJOHN ANNOUNCES NEW U.S. PACKAGING AND LABELING FOR HALCION
    KALAMAZOO, Mich., Nov. 18 /PRNewswire/ -- The Upjohn Company (NYSE: UPJ) announced today that it has agreed to new packaging and labeling for Halcion (triazolam) Tablets, following discussions with the U.S. Food and Drug Administration (FDA).  Halcion is the most widely prescribed sleeping medication in the world.
    Each new 10-tablet package will contain a patient package insert, a leaflet which advises consumers about the proper use of this medication and benzodiazepine sleep medications in general.
    "This is good news for patients, because it will enable them to become better informed about the medication they are using," said Upjohn's Chairman and Chief Executive Officer Theodore Cooper, M.D., Ph.D.  "The FDA is becoming increasingly committed to informing patients about their medications by means such as patient package inserts. Upjohn is pleased to use this vehicle to reinforce the information we provide to physicians."
    "The smaller package size," said Cooper, "is a further reminder that Halcion is intended for the short-term treatment of insomnia.  Halcion is safe and effective when it's used as recommended."
    In addition to the new package size and the patient information, Upjohn and the FDA have agreed to change the physician package insert for Halcion. The revisions to the physician package insert emphasize the appropriate use of Halcion in the treatment of insomnia, in particular the desirability of short-term treatment and the use of the smallest effective dose, as well as the need for careful initial and continuing evaluation of patients with complaints of insomnia.  The new labeling and the new package size will be introduced as soon as it is technically possible to make the changes, said Upjohn officials.
    The United Kingdom on Oct. 2 suspended Upjohn's license to market Halcion in that country; Upjohn is currently appealing that suspension.
    In mid-October the Committee for Proprietary Medicinal Products (CPMP), an advisory body for European Community (EC) member states, appointed a working group to review Halcion data and to make recommendations regarding Halcion use by mid-December.  Upjohn welcomed the move and said it would facilitate the efforts of the CPMP to make a fair and measured review of Halcion data and to avoid what the company has maintained was a precipitous action by U.K. regulatory authorities.
    Millions of patients in more than 90 countries have used Halcion since its introduction in Belgium in 1977.  Halcion was introduced in the U.S. in early 1983.
    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-                        11/18/91
    /CONTACT:  Kaye Bennett of The Upjohn Company, 616-323-4224/
    (UPJ) CO:  The Upjohn Company ST:  Michigan IN:  MTC SU: ML -- DE006 -- 1288 11/18/91 09:41 EST
COPYRIGHT 1991 PR Newswire Association LLC
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 1991 Gale, Cengage Learning. All rights reserved.

Article Details
Printer friendly Cite/link Email Feedback
Publication:PR Newswire
Date:Nov 18, 1991
Words:479
Previous Article:AIR PRODUCTS TO INCREASE PRICES OF ITS EMULSIONS
Next Article:PHILIPS AND BLOCKBUSTER ESTABLISH RELATIONSHIP
Topics:


Related Articles
UPJOHN TO DEFEND AND INDEMNIFY PHYSICIANS WHO PRESCRIBE HALCION
UPJOHN ENDORSES EC DECISION ON HALCION
UPJOHN ENDORSES EC DECISION ON HALCION
UPJOHN RESPONSE TO HALCION TV CHARGES
UPJOHN APPEALS HALCION SUSPENSION TO U.K. MEDICINES COMMISSION
ADVISORY COMMISSION RECOMMENDS HALCION RETURN TO U.K. MARKET
UPJOHN RESPONDS TO DALLAS VERDICT
UPJOHN WINS HOUSTON HALCION CASE
UPJOHN WINS LIBEL TRIAL IN U.K.

Terms of use | Copyright © 2017 Farlex, Inc. | Feedback | For webmasters