Dalvance Protocol Accord With FDA + Actavis Marketing = Home Run?
This article was originally published in The Pink Sheet Daily
Executive Summary
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.
You may also be interested in...
Actavis Buys Durata In Bolt-On Deal, Leaves Room For Transformation
Actavis snaps up Durata for less than $1 billion, with significant contingent value tied to success of antibiotic Dalvance; meanwhile Actavis will likely continuing pursuing M&A.
Dalvance: First QIDP Antibiotic Breaks New Regulatory Ground; Label Doesn’t
Durata has post-marketing requirements to continue resistance-related studies, but its label includes stewardship language similar to other antibiotics.
Dalvance Approval Is Durata’s GAIN: First Test Of FDA’s Antibiotics Incentives
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.