FDA Approves Antibiotic Dalvance for Skin Infections
TUESDAY, May 27, 2014 -- The U.S. Food and Drug Administration has approved the intravenous antibiotic Dalvance (dalbavancin) to treat methicillin-resistant Staphylococcus aureus (MRSA) and other potentially deadly bacterial skin infections resistant to older antibiotics.
Dalvance was given priority review and designated a "Qualified Infectious Disease Product" since it's meant to treat serious bacterial or fungal infections, the FDA said in a news release.
The drug's safety and effectiveness were evaluated in clinical studies involving nearly 1,300 people with acute bacterial skin infections. The most common side effects were nausea, headache and diarrhea. Study participants who took Dalvance also showed a higher-than-expected incidence of elevated liver enzymes in one screening test, the agency said.
Dalvance is marketed by Durata Therapeutics of Chicago.
The FDA has more about this approval.
Posted: May 2014