Orphan Medical Announces That Xyrem® Manufacturer Cleared by FDA

Minneapolis, MN - November 8, 2001

Orphan Medical, Inc. announced that the Food and Drug Administration (FDA) has cleared the Company's contract manufacturer to produce certain classes of drugs, including Xyrem® (sodium oxybate) oral solution. This action addresses one of the issues cited in the FDA's Approvable Letter issued to Orphan Medical on July 2, 2001. Other issues identified in the Approvable Letter were addressed in the Company's response submitted to the FDA on October 9, 2001(related story). Orphan Medical is seeking approval of Xyrem® as a treatment for the symptom of cataplexy in narcolepsy before the FDA's action deadline of April 9, 2002.

John H. Bullion, Chairman and Chief Executive Officer commented, "Resolution of these manufacturing issues is an important step toward approval of Xyrem®." Bullion added, "Since the FDA granted Xyrem® Priority Review status over a year ago, Orphan Medical has diligently responded to the agency's issues relating to the New Drug Application (NDA). We hope the remaining issues can be addressed promptly since Xyrem® addresses an unmet need for the treatment of cataplexy associated with narcolepsy. The importance of this medicine was recently reiterated by the Narcolepsy Network which presented its 2001 Medical Research Award to Orphan Medical for the Company's ongoing commitment and dedication to the development of Xyrem®."

Narcolepsy is a chronic neurological disorder affecting an estimated 100,000 to 125,000 Americans, whose main symptoms are excessive daytime sleepiness and cataplexy. Cataplexy is a debilitating symptom characterized by loss of muscle control in response to strong emotions such as laughter, anger, or surprise. In its most severe form, cataplexy can cause a person to collapse during waking hours.

Orphan Medical acquires, develops, and markets pharmaceuticals of high medical value for inadequately treated and uncommon diseases. The Company serves three strategic therapeutic market segments that are characterized by well-defined patient populations and served by physician specialists: oncology support, antidotes and sleep disorders. Orphan Medical's Internet Web site address is www.orphan.com.