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PAR PHARMACEUTICAL AND SUBSIDIARY REQUEST FDA TO WITHDRAW APPLICATIONS

PAR PHARMACEUTICAL AND SUBSIDIARY REQUEST FDA TO WITHDRAW APPLICATIONS
    SPRING VALLEY, N.Y., Nov. 4 /PRNewswire/ -- Pharmaceutical Resources, Inc. (NYSE, PSE: PRX), the recently-formed holding company of Par Pharmaceutical, Inc., announced today that Par and its subsidiary, Quad Pharmaceuticals, Inc., have voluntarily requested the Food and Drug Administration (FDA) to withdraw 97 of Quad's 106 currently approved Abbreviated New Drug Applications (ANDAs) and 23 of Par's more than 170 ANDAs.
    None of the products for which ANDA withdrawals are being requested are currently being manufactured or marketed by either firm, and most of them have not been manufactured or marketed for over 18 months.  Par said that it would conduct a recall of three products as to which it had ceased distribution earlier this year, but that it did not expect the financial effect of the recall to be material.
    The voluntary actions being undertaken are based upon information developed through the company's internal investigations and audits, independent audits made by an outside regulatory consultant, ongoing FDA inspections and assessments, and an investigation by and discussions with the Office of the United States Attorney for the District of Maryland concerning the status of Par's ANDAs.  The company also stated that it was recently informed by FDA that, pursuant to a finding by FDA in 1989 that Par submitted false and misleading information in filings with FDA, and because of the prior convictions of former company officials of making illegal payments to FDA employees, FDA will conduct validity assessments of the data and information in Par's ANDAs, and that it will not approve any new ANDAs or most supplements to existing ANDAs for Par until those assessments have been completed.
    Kenneth I. Sawyer, president and chief executive officer of Pharmaceutical Resources, Inc., said, "In anticipation of the FDA policy requiring this assessment, the company has been involved in an internally-directed validity assessment program for the last two years, which was designed to be used to assist FDA in reaching a prompt resolution of its review of our ANDAs.  We will cooperate fully with FDA in its ANDA assessments, and hope to help expedite the process."
    Sawyer further stated:  "Our independent auditors have conducted comprehensive and objective audits and investigations of many of these applications, and we acknowledge and appreciate the contribution of FDA and the Office of the U.S. Attorney to this process.  Indeed, we will continue to fully cooperate with FDA and the U.S. Attorney in their ongoing assessments and reviews of our ANDAs and operations.  We took the actions announced today because we believed that it was important to resolve the status of these applications.  In some cases, the reviews or audits of the ANDAs led to conclusions that information or representations submitted in support of the ANDAs was inaccurate or inadequate.  In some, we chose not to investigate questions raised about them because the products involved were no longer considered economically viable."
    Sawyer further commented:  "We will continue to direct our efforts to fulfilling our commitments to the government and the public, and to manufacture quality pharmaceutical products.  Par continues to market a broad line of generic pharmaceuticals and will welcome the day when rehabilitated companies such as Par will be permitted to secure new ANDA approvals for generic drug products of benefit to the public."
    -0-                       11/4/91
    /CONTACT:  Michael A. Swit, Esq., of Pharmaceutical Resources, 914-425-7100/
    (PRX) CO:  Pharmaceutical Resources, Inc.; Par Pharmaceutical, Inc.;
     Quad Pharmaceuticals, Inc. ST:  New York IN:  MTC SU: GK-KW -- NY062 -- 0807 11/04/91 14:42 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.

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Publication:PR Newswire
Date:Nov 4, 1991
Words:589
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