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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Lactobacillus acidophilus and Bifidobacterium animalis subsp. lactis
Date Designated: 03/24/2015
Orphan Designation: Prevention of necrotizing enterocolitis (NEC) in premature infants with very low birth weight less than or equal to 1500 grams
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Leadiant Biosciences, Inc.
9841 Washingtonian Blvd.
Suite 500
Gaithersburg, Maryland 20878
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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