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ROYCE LABORATORIES, INC. HAS FILED APPLICATIONS (ANDAs) FOR THREE NEW PRODUCTS

 MIAMI, Jan. 3 /PRNewswire/ -- Royce Laboratories, Inc. (NASDAQ: RLBAD) announced today that it has filed Abbreviated New Drug Applications (ANDAs) with the U.S. Food and Drug Administration (FDA) for three new products in seven dosage strengths.
 As announced on Dec. 17, 1993, the company has been released from the FDA's validity assessment policy (a/k/a/ the "application integrity policy"). As a result, the FDA will now resume substantive scientific review of ANDAs submitted by the company for the approval of new generic drugs.
 The recently filed ANDAs are for the following products:
 Pindolol (5 mg. and 10 mg.) is the generic equivalent of Sandoz's brand name product Visken(R). Visken(R) is a beta blocker (anti- hypertensive) with annual U.S. sales of approximately $35 million. Patent coverage for Visken(R) has expired.
 Cyclobenzaprine (10 mg.) is the generic equivalent of Merck & Co.'s brand name product Flexeril(R). Flexeril(R) is a muscle relaxant with annual U.S. sales of approximately $130 million. Patent coverage for Flexeril(R) has expired.
 Capoten (12.5 mg., 25 mg., 50 mg., and 100 mg.) the generic equivalent of Bristol-Myers Squibb's brand name product Captopril(R). Captopril(R) is an ACE-inhibitor (anti-hypertensive) with annual U.S. sales of approximately $600 million. Patent protection for Captopril(R) will expire on Aug. 8, 1995.
 In addition to the three recent filings, the company has four ANDAs in 10 dosage strengths pending with the FDA. The company intends to file a new ANDA for Piroxicam within the next few weeks. All of the company's pending ANDAs are subject to review and must ultimately be approved by the FDA before the company can ship any of these products. There can be no assurance that ANDAs will be approved for any of these products.
 Additionally, the company has approximately 10 additional products in various stages of development.
 Royce Laboratories, Inc. is a manufacturer of generic prescription and over the counter pharmaceuticals.
 -0- 1/3/94
 /CONTACT: Patrick J. McEnany, chief executive officer, Royce Laboratories, 305-624-1500/
 (RLABD)


CO: Royce Laboratories, Inc. ST: Florida IN: MTC SU:

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Publication:PR Newswire
Date:Jan 3, 1994
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