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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: mannitol
Trade Name: Bronchitol®
Date Designated: 02/11/2005
Orphan Designation: For use to facilitate clearance of mucus in patients with bronchiectasis and in patients with cystic fibrosis at risk for bronchiectasis
Orphan Designation Status: Designated/Approved
Pharmaxis Europe Limited
76 Furze Road, Dublin 18
Sandyford Business Park, Suite 108, Q house
Dublin D18 AY29
Ireland

The sponsor address listed is the last reported by the sponsor to OOPD.

Marketing approved:

1 Generic Name: mannitol
Trade Name: Bronchitol®
Marketing Approval Date: 10/30/2020
Approved Labeled Indication: as add-on maintenance therapy to improve pulmonary function in adult patients 18 years of age and older with cystic fibrosis. Use Bronchitol only for adults who have passed the Bronchitol Tolerance Test.
Exclusivity End Date: 10/30/2027 
Exclusivity Protected Indication* :  as add-on maintenance therapy to improve pulmonary function in adult patients 18 years of age and older with cystic fibrosis and who have passed the Bronchitol Tolerance Test
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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