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ROYCE LABORATORIES ANNOUNCES RECEIPT OF 'NOT APPROVABLE' LETTER FROM FDA

 ROYCE LABORATORIES ANNOUNCES RECEIPT
 OF 'NOT APPROVABLE' LETTER FROM FDA
 MIAMI, April 22 /PRNewswire/ -- Royce Laboratories, Inc. (NASDAQ: RLAB) announced that late yesterday afternoon it received a letter from the United States Food and Drug Administration ("FDA") advising the company that its two Abbreviated New Drug Applications ("ANDAs") for PIROXICAM (10mg and 20mg) are deficient and, therefore, are not approvable as submitted. In its letter, the FDA enumerated a number of discrepencies and inconsistencies associated with manufacturing and testing records for the Piroxicam applications.
 The FDA concluded that, in light of the inconsistencies and discrepancies, manufacturing of the test batches had not been satisfactorily documented. The FDA further advised the company that, "unless these issues are otherwise resolved to the satisfaction of the FDA...the only alternative would be to provide data on new test batches manufactured in accordance with Current Good Manufacturing Practices including the results of new bioequivalence studies as appropriate, to support approval of the products."
 The company is currently evaluating its options in light of this determination, as well as the long-term impact which this determination may have on its business. Through this date, the company has received substantial orders for Piroxicam (and has manufactured sufficient products to fill these initial orders), which at the present time cannot be shipped due to this determination. Depending on subsequent actions taken by the FDA and the company, respectively, it is possible that the company will sustain a write-off of approximately $1,500,000.
 It presently is unknown whether the events leading to this determination will have an impact on other aspects of the company's relationship with the FDA. The company intends to continue to fully cooperate with the FDA in this and all other matters in which the company is involved.
 Royce Laboratories, Inc. is a manufacturer of prescription and over-the-counter generic pharmaceuticals.
 -0- 4/22/92
 /CONTACT: Patrick J. McEnany, president of Royce Laboratories, Inc., 305-624-1500/
 (RLAB) CO: Royce Laboratories, Inc. ST: Florida IN: MTC SU:


JJ-AW -- FL002 -- 1137 04/22/92 10:07 EDT
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Publication:PR Newswire
Date:Apr 22, 1992
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