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Thalomid Receives FDA Orphan Drug Designation For Crohn's Disease WARREN, NJ -- April 15, 1999 -- The United States Food and Drug Administration has granted Orphan Drug designation to Celgene Corp.'s Thalomid(TM) (thalidomide) for the treatment of Crohn's disease, a chronic inflammatory disease of the intestinal tract. Thalomid is currently being tested in a phase II clinical study at Cedar's Sinai, Los Angeles for its use in Crohn's Disease. Preliminary findings from this trial will be presented at Digestive Disease Week, May 16-19, 1999 in Orlando, FL. Orphan drug designation entitles Celgene to exclusive marketing rights in the United States on thalidomide for seven years following marketing approval and enables the company to obtain research funding, tax credits for certain research expenses and a waiver from the application user fee. The FDA has already approved Thalomid for the treatment of erythema nodosum leprosum (ENL) in leprosy. Thalidomide is contraindicated in pregnant women and women capable of becoming pregnant. Even a single capsule taken by a pregnant woman can cause severe birth defects or death to an unborn baby. The major adverse drug reactions known to be associated with thalidomide treatment include: peripheral neuropathy, a common, potentially severe side effect that may be irreversible; drowsiness/somnolence; dizziness/orthostatic hypotension; neutropenia; and increased HIV-viral load. Related Links: thalidomide, Celgene Corp. E-mail this page to a friend or colleague! To print, use this version