FDA approves Dalvance to treat skin infections

FDA

The U.S. Food and Drug Administration today approved Dalvance (dalbavancin), a new antibacterial drug used to treat adults with skin infections.

Dalvance is intended to treat acute bacterial skin and skin structure infections (ABSSSI) caused by certain susceptible bacteria like Staphylococcus aureus(including methicillin-susceptible and methicillin-resistant strains) andStreptococcus pyogenes. The treatment is administered intravenously.

Dalvance is the first drug designated as a Qualified Infectious Disease Product (QIDP) to receive FDA approval. Under the Generating Antibiotic Incentives Now (GAIN) title of the FDA Safety and Innovation Act, Dalvance was granted QIDP designation because it is an antibacterial or antifungal human drug intended to treat serious or life-threatening infections.

For more details, go to: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm398724.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

Michael Wonder

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Michael Wonder

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