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PHARMACEUTICAL RESOURCES ANNOUNCES FDA CLEARANCE TO ALLOW COMPANY TO SEEK NEW PRODUCT APPROVALS

 SPRING VALLEY, N.Y., Oct. 26 /PRNewswire/ -- Pharmaceutical Resources, Inc. (NYSE: PRX), the holding company of Par Pharmaceutical, Inc., today announced that it has been informed by the U.S. Food and Drug Administration (FDA) that it will now review applications submitted by Par Pharmaceutical for approval of new generic drugs.
 Kenneth I. Sawyer, president and chief executive officer of Pharmaceutical Resources, commented, "Par's resolution of the FDA's Application Integrity Assessment Program marks a significant milestone and achievement in our company's history." For the first time in more than four years, Par will be able to have new drug applications reviewed for approval and to have submissions currently pending within the FDA reviewed. During the period of the FDA assessment, the company established and built a new research and development capability. As a result, the company expects to file submissions for ANDAs as soon as possible.
 In announcing completion of this program, Mr. Sawyer commented, "This represents the final chapter in our effort to gain the assurance of the government and the public in the integrity of our company and its products. While this process has been both lengthy and arduous, we have emerged stronger and more proficient. We have a great appreciation of the privilege and trust we hold to provide important medicines to the American people. This appreciation guides our future."
 Pharmaceutical Resources, Inc. is a holding company with subsidiaries that research, manufacture, market and develop a broad line of generic drugs.
 -0- 10/26/93
 /CONTACT: June Filingeri or Lisa Carlton of Morgen-Walke Associates, 212-850-5600/
 (PRX)


CO: Pharmaceutical Resources, Inc.; Par Pharmaceutical, Inc. ST: New York IN: MTC SU:

CK -- NY007 -- 6699 10/26/93 08:12 EDT
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Publication:PR Newswire
Date:Oct 26, 1993
Words:281
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