Search Orphan Drug Designations and Approvals
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Generic Name: | MANNITOL | ||||||||||||||||
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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 | ||||||||||||||||
Sponsor: |
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. |
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Marketing approved: |
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1 | Generic Name: | MANNITOL |
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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 | |
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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