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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: human gammaglobulin
Date Designated: 09/16/2002
Orphan Designation: Treatment of gastrointestinal disturbances (to include constipation, diarrhea, and abdominal pain) associated with regression-onset autism in pediatric patients.
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Latona Life Sciences, Inc.
10 Village St.
Mills, Massachusetts 02054
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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