NEWS

Medicines Development for Global Health Announces Submission of the Moxidectin NDA to the FDA and Priority Review Designation

December 16, 2017

Medicines Development for Global Health is pleased to announce the submission of a New Drug Application for moxidectin as an oral treatment for river blindness to the US Food and Drug Administration (FDA). The FDA have also confirmed that moxidectin has qualified for priority review.

The FDA designates drugs for priority review that treat a serious condition and, if approved, would provide a significant improvement in safety or effectiveness. With the designation, the FDA now aims to review the moxidectin registration application within six months (compared with a standard review period of 10 months). If the application is approved, MDGH will receive a transferable Priority Review Voucher that entitles the holder to priority review of another drug or therapy by the FDA.

Please see press release for further details.