FDA approves Dalvance injection for ABSSSI - Durata Therapeutics
The FDA has approved Dalvance (dalbavancin), from Durata Therapeutics, for injection for the treatment of adult patients with Acute Bacterial Skin and Skin Structure Infections (ABSSSI) caused by susceptible Gram-positive bacteria, including methicillin-resistant Staphylococcus aureus (MRSA).
Two Phase III trials, DISCOVER 1 and DISCOVER 2 were conducted under a Special Protocol Assessment with the FDA and included more than 1,300 patients with ABSSSI. The clinical trials showed DALVANCE was non-inferior to the comparator regimen and met its primary and secondary endpoints of early response, measured at 48 to 72 hours of therapy, and clinical success at the end of treatment in patients with very large skin lesions and high frequencies of fever.
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