ROYCE LABORATORIES ANNOUNCES RECEIPT OF FDA LETTER
ROYCE LABORATORIES ANNOUNCES RECEIPT OF FDA LETTER MIAMI, July 8 /PRNewswire/ -- Royce Laboratories, Inc.
(NASDAQ: RLAB) announced today that it has received a letter from the Food and Drug Administration ("FDA") that states that the FDA has concluded that the company "submitted false or misleading information in ANDAs filed with the (FDA)" and that as a result of this conclusion the company will be expected to comply with FDA policies regarding false or misleading information including: to aid the FDA in the assessment of the validity of the company's approved and pending ANDAs and take corrective actions as are required. Depending upon the results of the validity assessments, corrective actions may require, without limitation, modifications to the company's manufacturing procedures, the institution of new training programs, or the supplementing or withdrawal of additional ANDAs. Until the validity assessment for each product is completed, it is impossible to determine what corrective action(s) will be required. These validity assessments and corrective actions must be completed prior to any further review of the company's pending ANDAs (including its ANDAs for Piroxicam) by the FDA. The company intends to cooperate fully with the FDA in regard to the validity assessments.
As previously reported, the company has voluntarily withdrawn its ANDAs for Minoxidil and Haloperidol, and has received a "not approvable" letter with respect to its ANDAs for Piroxicam. None of the company's current executives, and none of the company's current personnel responsible for product development and FDA compliance, were employed by the company when the company's ANDAs for Minoxidil and Haloperidol were filed and approved. The company believes that the FDA has taken these actions as a result of their findings with respect to Minoxidil, Haloperidol and Piroxicam (the details of which have previously been reported). Further, as previously reported, the company has already commenced an audit of its approved and pending ANDAs by the company's regulatory consultants. The company hopes to meet with FDA in the near future to consider the matters raised in the FDA's letter and to determine the course of action to be taken by the company to satisfy the FDA's concerns. While the company fully expects to be able to resolve the FDA's concerns, there is no assurance of the timing or ultimate results of these efforts. However, the FDA's actions will further delay the receipt of approvals for the company's pending ANDAs (including those for Piroxicam). While the extent of such further delays cannot be determined with any certainty, it can be anticipated that such further delays will be for not less than a 90 day period. Royce Laboratories, Inc. is a manufacturer of prescription and over- the-counter generic pharmaceuticals. -0- 7/8/92 /CONTACT: Patrick J. McEnany, president of Royce Laboratories, Inc., 305-624-1500/ (RLAB) CO: Royce Laboratories, Inc. ST: Florida IN: MTC SU:
JB-AW -- FL004 -- 7301 07/08/92 09:22 EDT
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|Date:||Jul 8, 1992|
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