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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: (R)-N-[2-(6-chloro-5-methoxy-1H-indol-3-yl)propyl]acetamide
Date Designated: 10/03/2001
Orphan Designation: Treatment of circadian rhythm sleep disorders in blind people with no light perception
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Phase 2 Discovery, Inc.
3130 Highland Avenue, Third Floor
Cincinnati, Ohio 45219
United States

The sponsor address listed is the last reported by the sponsor to OOPD.

*Exclusivity Protected Indications are shown for approvals from 01/01/2013 to the present.
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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