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PHARMANEX, INC. v. SHALALA

No. 2:97 CV 0262 K.

35 F.Supp.2d 1341 (1999)

PHARMANEX, INC., a Delaware corporation authorized to do business in the State of Utah, Plaintiff, v. Donna SHALALA, in her official capacity as Secretary of the United States Department of Health and Human Services, and Michael Friedman, in his official capacity as First Deputy Commissioner of the Food and Drug Administration, Defendants.

United States District Court, D. Utah, Central Division.

February 16, 1999.

Attorney(s) appearing for the Case

Richard M. Hymas, Earl J. Peck, Nielsen & Senior, Salt Lake City, UT, Stuart M. Pape, Daniel A. Kracov, Patton Boggs & Blow, Washington, DC, Alan L. Sullivan, Robert W. Payne, Todd M. Shaughnessy, Snell & Wilmer LLP, Salt Lake City, UT, Richard M. Cooper, Helen I. Dooley, Williams & Connolly, Washington, DC, James S. Jardine, Rick B. Hoggard, Mr., Ray Quinney & Nebeker, Salt Lake City, UT, Brent M. Burningham, Marketstar Corp., Ogden, UT, for Pharmanex.

Bill Ryan, U.S. Attorney's Office, Jacqueline H. Eagle, U.S. Department of Justice, Washington, DC, Neal Parker, Food and Drug Administration, Rockville, MD, for Donna Shalala

Bill Ryan, U.S. Attorney's Office, U.S. Department of Justice, Washington, DC, for Michael Friedman.

Jacqueline H. Eagle, U.S. Department of Justice, Washington, DC, Neal Parker, Food and Drug Administration, Rockville, MD, for Food and Drug Administration.

Alan Charles Raul, Sidley & Austin, Washington, DC, for National Nutritional Foods, amicus.

Paul Wood, Littlefield & Peterson, Salt Lake City, UT, for National Organization For Rare Disorders, amicus.

ORDER

KIMBALL, District Judge.

Plaintiff Pharmanex, Inc. ("Pharmanex") filed this case seeking judicial review of an administrative decision issued by the Food and Drug Administration ("FDA") on May 20, 1998 (the "FDA Decision"). In that decision, FDA ruled that Cholestin, a product marketed by Pharmanex, is a drug, rather than, as Pharmanex contends, a dietary supplement. Pharmanex seeks an order holding the FDA Decision unlawful under the Administrative...

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