Dalvance Approval Is Durata’s GAIN: First Test Of FDA’s Antibiotics Incentives
This article was originally published in The Pink Sheet Daily
Durata has honor of having first drug approved under Qualified Infectious Disease Product designation and gains the benefits of an added five years of market exclusivity.
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With a Special Protocol Agreement and an experienced sales team lined up, all the firm has to do now is get hospitals excited about an expensive antibiotic in a highly-genericized market.
CMS disappointed stakeholders looking for antibiotic payment incentives from Medicare with two recent decisions. One was to withhold new technology add-on payments from Dalvance and the other to allow existing NTAP benefits for Dificid to expire.
Durata has post-marketing requirements to continue resistance-related studies, but its label includes stewardship language similar to other antibiotics.