Massive disappointment for Veloxis
FDA has blocked Veloxis from launching its main asset Envarsus until the summer of 2016, although the drug has been granted tentative approval. The Danish biotech says it will appeal the decision.
BY BENJAMIN WERNER CHRISTENSEN & STEFAN SINGH KAILAY
The US medicine approval authority, FDA, says it will not approve Veloxis’ drug Envarsus before the period of exclusivity for Astellas Pharma’s Astagraf XL expires on July 19, 2016, Veloxis informs in a stock market wire.
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