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ROYCE LABORATORIES ANNOUNCES WITHDRAWAL OF ANDAs FOR HALOPERIDOL

 ROYCE LABORATORIES ANNOUNCES WITHDRAWAL OF ANDAs FOR HALOPERIDOL
 MIAMI, May. 4 /PRNewswire/ -- Royce Laboratories, Inc. (NASDAQ: RLAB) today announced that it has voluntarily requested that the United States Food and Drug Administration ("FDA") withdraw, without prejudice, its approved abbreviated new drug applications ("ANDAs") for Haloperidol. The company's 1991 sales of Haloperidol, the generic equivalent of McNeil's Haldol, were $345,000. The company intends to conduct a recall of these products.
 The company's ANDAs for Haloperidol were recently the subject of FDA examinations, which pointed out a number of discrepancies in the underlying data that supported the filings which were made by the company in 1986 and 1987. Based upon subsequent investigations by company personnel and one of its regulatory consultants, the company has concluded that although there may be legitimate explanations for these discrepancies, it appears to the company that certain aspects of the filed applications were not based on all of the data available, and that there is insufficient documentation to justify some of the instances where certain data was not included in the filings. Based on the company's inability to verify legitimate explanations for the above, the company has concluded that the proper course of action at this time is to voluntarily withdraw these ANDAs.
 The withdrawal of the company's ANDAs for Haloperidol represents the second withdrawal by the company this year, and follows the company's April 1992 withdrawal of its ANDAs for Minoxidil. The company's ANDAs for Minoxidil and Haloperidol were filed with the FDA in 1986 and 1987, and were approved by the FDA in 1987. None of the company's present executives and none of the persons at the company currently responsible for product development and for FDA filings were with the company when its ANDAs for Minoxidil and Haloperidol were filed or approved.
 Patrick J. McEnany, the company's president, stated: "As a result of what we and the FDA have discovered over the last few weeks, we feel that the actions we are taking, and have taken since these matters came to light, were the right ones under the circumstances. Our primary goal will always be to protect the interests of our customers and the users of our products."
 Royce Laboratories, Inc. is a manufacturer of prescription and over the counter generic pharmaceuticals.
 -0- 5/4/92
 /CONTACT: Patrick J. McEnany, president of Royce Laboratories, Inc., 305-624-1500/
 (RLAB) CO: Royce Laboratories, Inc. ST: Florida IN: MTC SU:


JB-SS -- FL001 -- 5878 05/04/92 09:20 EDT
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Publication:PR Newswire
Date:May 4, 1992
Words:411
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