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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: lactic acid bacteria (Lactobacilli, Bifidobacteria, and Steptococci)
Date Designated: 01/15/2002
Orphan Designation: Treatment of active chronic pouchitis
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
VSL Pharmaceuticals, Inc.
800 S. Frederick Ave.
Gaithersburg, Maryland 20877
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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