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ROYCE LABORATORIES VOLUNTARILY WITHDRAWS APPLICATIONS FOR MINOXIDIL

ROYCE LABORATORIES VOLUNTARILY WITHDRAWS APPLICATIONS FOR MINOXIDIL
 MIAMI, April 6 /PRNewswire/ -- Royce Laboratories, Inc. (NASDAQ: RLAB) announced that the company has voluntarily withdrawn its Abbreviated New Drug Applications (ANDA) for Minoxidil (2.5mg and 10mg). These applications had been approved by the U.S. Food and Drug Administration (FDA) in November of 1987. The company in cooperation with the FDA have discovered discrepancies in the original submissions, that were filed with the FDA in April, 1986, and as a result Royce has voluntarily withdrawn these ANDAs. The company's sales of Minoxidil in 1991 were $480,925. At the present time the company intends to conduct another bio-study for Minoxidil and to submit a new ANDA for the product. Minoxidil is the generic equivalent to Loniten, an anti-hypertensive manufactured by Upjohn.
 In addition, Pfizer's market exclusivity for Feldene expires today. On Sept. 9, 1991, Royce received tentative approval for Piroxicam, the generic equivalent to Feldene, from the FDA. Final approval is pending the expiration of the patent and marketing exclusivities, as well as the company remaining in substantial compliance with good manufacturing practices. The FDA is completing its review of the company's application, and upon the anticipated receipt of final approval the company intends to commence shipments of Piroxicam.
 Royce Laboratories, Inc. is a manufacturer of prescription and over the counter generic pharmaceuticals.
 -0- 4/6/92 R
 /CONTACT: Patrick J. McEnany, president of Royce Laboratories, Inc., 305-624-1500/
 (RLAB) CO: Royce Laboratories, Inc. ST: Florida IN: MTC SU:


TS -- FL006R -- 5665 04/07/92 07:53 EDT
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Publication:PR Newswire
Date:Apr 7, 1992
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