Biopharm Requests FDA Hearing in Regard to New Drug Applications.BELLPORT, N.Y--(BUSINESS WIRE)--Aug. 31, 1998--On Aug. 25, 1998, current management became aware of a letter that was sent to Biopharmaceutics, Inc. (OTCBB OTCBB See OTC Bulletin Board (OTCBB). :BOPM BOPM Blitzed Open Proxy Monitor BOPM Base of the Pyramid Market (economics) ) from the Food and Drug Administration on or around May 29, 1998. In this letter, the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. stated that subject to a hearing on the matter, it is proposing to issue an order to debar de·bar tr.v. de·barred, de·bar·ring, de·bars 1. To exclude or shut out; bar. 2. To forbid, hinder, or prevent. the company for a period of ten years from submitting, or assisting in the submission of any abbreviated drug application. The FDA proposal is based on a finding that Biopharmaceutics was convicted of felonies in 1993, relating to the development or approval of abbreviated drug applications regulated under the Federal Food, Drug and Cosmetic Act Federal Food, Drug and Cosmetic Act a regulation in the United States which requires all drugs used in animals to be approved by the Food and Drug Administration. . Biopharmaceutics' Acting President, Jonathan Rosen said: "It appears that in the late 1980's, a number of employees of the company were responsible for certain unauthorized acts. Apparently, these employees were terminated as a result, but that did not preclude the FDA from taking disciplinary action. From whatwe know, the FDA is now choosing to apply further sanctions because of a corporate Consent Decree based upon the aforesaid Before, already said, referred to, or recited. This term is used frequently in deeds, leases, and contracts of sale of real property to refer to the property without describing it in detail each time it is mentioned; for example,"the aforesaid premises. unauthorized acts resulting in a conviction some five years ago. I have referred the matter to company's counsel." This press release contains forward looking statements within the meaning of Section 21A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and are subject to the safe harbors created thereby. Actual results could differ materially from those projected in the forward looking statements.
CONTACT: Biopharmaceutics Inc., Bellport
Jonathan Rosen, 516/286-5800
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