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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: Gamma hydroxybutyrate
Date Designated: 12/03/1987
Orphan Designation: Treatment of narcolepsy and the auxiliary symptoms of cataplexy, sleep paralysis, hypnagogic hallucinations and automatic behavior.
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Biocraft Laboratories, Inc.
18-01 River Road
Fair Lawn, New Jersey 07410
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.