The Food and Drug Administration May 23 approved Dalvance (dalbavancin), a new antibacterial drug used to treat adults with certain skin infections.
Dalvance is intended to treat acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible bacteria like Staphylococcus aureus (including methicillin-susceptible and methicillin-resistant strains) and Streptococcus pyogenes, the agency said. It is administered intravenously.
Dalvance is marketed by Chicago-based Durata Therapeutics Inc.
QIDP Designation.
Dalvance is the first drug designated as a qualified infectious disease product (QIDP) to receive FDA approval, the agency said.
Under the Generating Antibiotic Incentives Now (GAIN) Act, which was part of the ...
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