The U.S. Food and Drug Administration approved Dalvance (dalbavancin), a new antibacterial drug for treatment of skin infections in adults.
The drug is intended to treat acute bacterial skin and skin structure infections caused by certain susceptible bacteria like Staphylococcus aureus, including methicillin-susceptible and methicillin-resistant strains, and Streptococcus pyogenes. The treatment is administered intravenously.
Dalvance is the first drug designated as a Qualified Infectious Disease Product to receive FDA approval. It was granted QIDP designation because it is an antibacterial or antifungal human drug intended to treat serious or life-threatening infections. As a QIDP, the drug was also given priority review.
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