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Veloxis Gains Orphan Status for Envarsus

Once-daily formulation offers potential in kidney transplants

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By: Kristin Brooks

Managing Editor, Contract Pharma

Veloxis Pharmaceuticals was granted Orphan Drug status by the FDA for Envarsus for prevention of organ rejection in patients receiving allogenic kidney transplants. Envarsus is a once-daily formulation of tacrolimus employing the company’s MeltDose technology.   Orphan drug designation is granted for potential treatments that target a patient population of 200,000 or less. For Envarsus, the designation is based on the potential that Envarsus may be clinically superior to currently marketed...

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