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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: bifidobacterium longum subsp. infantis
Date Designated: 05/06/2025
Orphan Designation: prevention of necrotizing enterocolitis (NEC) in infants gestational age <34 weeks and/or very low birth weight (<1,500 grams) infants
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Infinant Health, Inc.
2121 2nd Street, Suite 108
Davis, California 95618
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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