Company / News & Insights / ReveraGen Completes NDA Submission to FDA for Vamorolone in Duchenne Muscular Dystrophy

ReveraGen Completes NDA Submission to FDA for Vamorolone in Duchenne Muscular Dystrophy

Pace ® is happy to share news from our client, ReveraGen BioPharma Inc., on a significant accomplishment! ReveraGen Completes NDA Submission to FDA for Vamorolone in Duchenne Muscular Dystrophy.

Pace® Ann Arbor (legacy Velesco Pharmaceutical Services) contributed significantly to this success. Velesco Pharma (now Pace®) performed the drug product clinical formulation development and all drug product analytical method development to support this program. Velesco Pharma (now Pace®) developed and manufactured the first clinical suspension product used in their initial human trials and modified/improved that formulation throughout the development lifecycle. Velesco Pharma (now Pace®) analytical teams developed and validated the assay/related substances methods for both the active and preservatives, drug release dissolution method, and critical physical quality attribute methods, such as viscosity.

Velesco Pharma (now Pace®) helped to reach final deliverables by supporting ongoing compassionate-use drug product manufacture and labeling as ReveraGen worked with their partner towards commercialization.

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