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KABI SIGNS CONSENT DECREE WITH FDA,

 PISCATAWAY, N.J., Aug. 2 /PRNewswire/ -- Kabi Pharmacia Inc. has signed a consent decree with the U.S. Food and Drug Administration (FDA) under which the company agreed to correct sales, advertising and promotional activities for Dipentum (olsalazine sodium). Dipentum is a prescription drug approved in July 1990 for the maintenance of remission of ulcerative colitis in patients who are intolerant of sulfasalazine.
 "The consent decree does not question the safety or efficacy of Dipentum when used as directed in the approved labeling, nor does it require any discontinuation of its sales and availability," a Kabi spokesman said.
 Kabi and the FDA made clear that patients now taking the drug should continue to do so unless instructed otherwise by their physicians.
 FDA alleged that promotional activities for Dipentum were violative of FDA law and regulations that prohibit false and misleading advertising and promotion of drugs, including for uses not in the official labeling. Kabi voluntarily suspended its promotion activities in April 1993 when it learned of FDA's conclusion that the materials and activities were violative.
 Under the consent decree, Kabi agreed to:
 -- retrieve from its sales representatives and destroy all promotional materials for Dipentum regarded by FDA as violative;
 -- submit to FDA for advance approval all advertising and promotion materials for Dipentum for the next year;
 -- not make any claims in advertising and promotional materials that Dipentum is safe and effective for uses for which it is not approved or make any misleading claims about the product as compared to sulfasalazine.
 -- train Kabi's employees in methods to assure compliance with FDA advertising regulations and with the consent decree;
 -- conduct a remedial advertising program, including a "Dear Doctor" letter and a corrective advertising campaign to appear in six medical journals for six months.
 The consent decree also requires Kabi to pay $85,000 to cover the costs of FDA's investigation and to set aside $300,000 to finance the remedial activities.
 "We signed this consent decree, in which there are no admissions of wrongdoing, because we felt that it was in the best interests of patients, physicians and our employees to put this incident behind us and to move forward on a positive note," said Anders Wiklund, chief executive officer of Kabi, who also signed the decree. "We cooperated fully with the FDA in reaching this agreement and we intend to comply fully with its terms."
 -0- 8/2/93
 /CONTACT: Kim Kent for Kabi Pharmacia, 202-833-4241/


CO: Kabi Pharmacia Inc.; U.S. Food and Drug Administration ST: New Jersey IN: MTC SU:

TW -- DC006 -- 8252 08/02/93 10:00 EDT
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Publication:PR Newswire
Date:Aug 2, 1993
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