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Executive Summary

ROYCE LABS MUST AUDIT ALL APPROVED AND PENDING ANDAs, FDA has told the firm. Royce said July 8 that it has received a letter from FDA stating that the company "submitted false or misleading information in ANDAs field" with the agency. "As a result of this conclusion the company will be expected to comply with FDA policies regarding false or misleading information," Royce said, and must aid FDA "in the assessment of the validity of the company's approved and pending ANDAs and take corrective actions as are required." Royce currently markets eight products and has six pending ANDAs. Corrective actions could include modifications to manufacturing procedures, new training programs, or supplements or withdrawals of ANDAs, the firm noted. The pending ANDAs include piroxicam. FDA told Royce that its generic version of Pfizer's nonsteroidal anti-inflammatory drug Feldene was "not approvable" on April 21 ("The Pink Sheet" April 27, T&G-1). A spokesperson said that Royce "recently" sent FDA supplemental information for piroxicam but has not yet received a response. Royce has withdrawn two ANDAs in recent months: the firm requested withdrawal of its ANDAs for haloperidol (a generic version of McNeil's Haldol) in May ("The Pink Sheet" May 11, In Brief) and minoxidil (Upjohn's brandname product is Loniten) in April, due to the discovery of "discrepancies" in the ANDA filings. "The company believes that the FDA has taken these actions [the audit of all approved and pending ANDAs] as a result of their findings with respect to minoxidil, haloperidol and piroxicam," Royce said. The company already has begun an internal audit. Royce "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," the release adds. "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," Royce noted. Approvals for pending ANDAs will almost certainly be delayed for at least another 90 days, according to the company. Royce recently added former Danbury Director of Regulatory Affairs Loren Gelber, PhD, to the new position of VP/regulatory compliance. Gelber's previous experience also includes 11 years with FDA as an analytical chemist and later a review chemist in the Division of Generic Drugs. Royce is still actively marketing eight products which the firm does not expect to be affected in the near-term. However, the withdrawal of haloperidol and minoxidil will have a significant adverse effect on financials: the two products together accounted for close to half of Royce's $2 mil. in revenues in 1991. Royce has raised about $10 mil. in equity in the last two years, in part on the prospect of a piroxicam approval. Royce currently has $5 mil. in cash and is in "fine financial position," the company said.

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