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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: Bovine whey protein concentrate
Date Designated: 09/30/1993
Orphan Designation: Treatment of cryptosporidiosis caused by the presence of Cryptosporidium parvum in the gastrointestinal tract of patients who are immunodeficient/immunocompromised or immunocompetent.
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Biomune Systems, Inc.
540 Arapeen Drive, Suite 202
Salt Lake City, Utah 84108
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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