Santhera and ReveraGen Complete NDA Submission to FDA for Vamorolone in Duchenne

 Santhera Pharmaceuticals (SIX: SANN) and ReveraGen BioPharma, Inc announce that they have completed the rolling submission of a new drug application (NDA) to the U.S. Food and Drug Administration (FDA), seeking priority review for vamorolonefor the treatment of Duchenne muscular dystrophy (DMD). Subject to approval, vamorolone is set to become available to patients in the U.S. in H2-2023.

https://www.biospace.com/article/releases/santhera-and-reveragen-complete-nda-submission-to-fda-for-vamorolone-in-duchenne-muscular-dystrophy/