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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: moxidectin
Trade Name:
Date Designated: 09/29/2010
Orphan Designation: Treatment of onchocerciasis volvulus in children and adults
Orphan Designation Status: Designated/Approved
Medicines Development for Global Health Limited
Level 1, 18 Kevanagh Street
Southbank VIC 3006
Melbourne
Australia

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

Marketing approved:

1 Generic Name: moxidectin
Trade Name:
Marketing Approval Date: 06/13/2018
Approved Labeled Indication: Moxidectin Tablets are indicated for the treatment of onchocerciasis due to Onchocerca volvulus in patients aged 12 years and older
Exclusivity End Date: 06/13/2025 
Exclusivity Protected Indication* :  Moxidectin Tablets are indicated for the treatment of onchocerciasis due to Onchocerca volvulus in patients aged 12 years and older
2 Generic Name: moxidectin
Trade Name:
Marketing Approval Date: 02/07/2025
Approved Labeled Indication: treatment of onchocerciasis due to Onchocerca volvulus in adult and pediatric patients aged 4 years and older and weighing at least 13 kg
Exclusivity End Date: TBD  
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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