Dalvance receives FDA approval

SILVER SPRING, Md. — The Food and Drug Administration on Friday approved Dalvance (dalbavancin), a new antibacterial drug used to treat adults with acute bacterial skin and skin structure infections, such as staphylococcus aureus (including methicillin-susceptible and methicillin-resistant strains) and streptococcus pyogenes.

Dalvance is the first drug to be designated as a qualified infection disease product to receive the agency's approval. It was granted QIDP status because it is an antibacterial or antifungal human drug intended to treat serious or life-threatening infections, according to the FDA.

Dalvance, which is adminstered intravenously, was granted priority review. The drug's QIDP designation qualifies it for an additional five years of marketing exclusivity. Dalvance is marketed by Durata Therapeutics, which is based in Chicago.

 

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