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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Bacillus thuringiensis crystal protein (Cry5B)
Date Designated: 03/07/2018
Orphan Designation: Treatment of gastroinstestinal infections caused by ascaris lumbricoides (roundworm), trichuris trichiura (whipworm), ancylostoma duodenale, necator americanus, and ancylostoma ceylanicum (hookworms)
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
University of Massachusetts Medical School
373 Plantation Street
Two Biotech, Suite 219
Worcester, Massachusetts 01605
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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