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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: omadacycline p-toluenesulfonate
Date Designated: 04/26/2026
Orphan Designation: post-exposure prophylaxis (PEP) of anthrax infection
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Paratek Pharmaceuticals, Inc.
1000 First Avenue
Suite 200
King of Prussia, Pennsylvania 19406
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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