Dayton Reardan, Orphan Medical Vice-President of Regulatory Affairs, Receives Special Award From FDA Commissioner.Business Editors/Health/Medical Writers MINNEAPOLIS--(BUSINESS WIRE)--May 5, 2004 Orphan Medical, Inc. (Nasdaq:ORPH) announced today that Vice President of Regulatory Affairs Dayton T. Reardan, Ph.D., RAC See remote access concentrator. , was selected to receive the Food and Drug Administration's (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. ) Commissioner's Special Citation. The Commissioner's Special Citation is granted solely at the Commissioner's discretion for contributions and accomplishments the Commissioner deems appropriate to recognize for their contribution to the mission of the Food and Drug Administration: To protect the public health, as directed by the Federal Food, Drug, and Cosmetic Act The United States Federal Food, Drug, and Cosmetic Act (abbreviated as FFDCA, FDCA, or FD&C), is a set of laws passed by Congress in 1938 giving authority to the Food and Drug Administration (FDA) to oversee the safety of food, drugs, and cosmetics. , and to administer the statutory framework of this law by providing new and better products. The awardee receives a wooden triblock with a Harvey Wiley medallion. Dr. Harvey Wiley was the first administrator of the Federal Food and Drug Law -- predecessor to later day FDA Commissioners. He served from 1907 to 1912. Before being appointed by President Theodore Roosevelt to head the agency implementing the newly signed Pure Food and Drug Act This is an article about the United States Food and Drug Act; for the Canadian version see Food and Drugs Act. For the band see Pure Food and Drug Act (band). The Pure Food and Drug Act (1906), Dr. Wiley had been conducting laboratory studies on food adulteration as part of his job with the Department of Agriculture. Marlene E. Haffner, M.D., Director of the FDA Office of Orphan Products Development commented, "It is due to the dedication of people like Dr. Reardan that products treating rare diseases now serve over 12 million patients in the United States." "This citation is a tribute to Orphan Medical's commitment to patients with rare and underserved medical conditions as well as our shareholders who provided the capital to develop important new medications. Dayton represents the entire staff at our Company who have made personal commitments to ensure that these medications are brought to market and we thank the FDA for this recognition," said John Bullion, Orphan Medical Chief Executive Officer. "His commitment and leadership have been key in the success we have had in bringing seven products to market in our nearly ten-year history and in particular with the approval of Xyrem which is a key to the future of the Company." Orphan Medical acquires, develops, and markets pharmaceuticals of high medical value for inadequately treated and uncommon CNS See Continuous net settlement. CNS See continuous net settlement (CNS). diseases treated by specialist physicians. The lead product for the Company is Xyrem(R) (sodium oxybate) oral solution, which is the first and only approved treatment for cataplexy cataplexy /cat·a·plexy/ (kat´ah-plek?se) a condition marked by abrupt attacks of muscular weakness and hypotonia triggered by such emotional stimuli as mirth, anger, fear, etc., often associated with narcolepsy. associated with narcolepsy narcolepsy, a sleep disorder characterized by excessive daytime sleepiness and recurring unwanted episodes of sleep ("sleep attacks"). People with narcolepsy may abruptly fall asleep at almost any time, including while talking, eating, or even walking. . Xyrem is also being assessed as a treatment for the full range of narcolepsy symptoms including excessive daytime sleepiness excessive daytime sleepiness Sleep disorders A subjective difficulty in maintaining an awake state, and an increase ease of falling asleep when the person is sedentary; EDS may be quantified with subjective rating scales of sleepiness . Orphan Medical's pipeline includes development stage products for fibromyalgia and pain. Orphan Medical's Internet Web site address is www.orphan.com The information in this press release may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and of 1995. A number of factors could cause actual results to differ materially from the Company's assumptions and expectations. These are set forth in the cautionary statements included in Orphan Medical's most recent Form 10-Q or Form 10-K filed with the Securities and Exchange Commission. (These documents can be accessed through the Orphan Medical Web site at http://www.orphan.com). All forward-looking statements are qualified by, and should be considered in conjunction with, such cautionary statements. |
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