The intravenous antibiotic Dalvance (dalbavancin) has been approved by the U.S. Food and Drug Administration to treat methicillin-resistant Staphylococcus aureus (MRSA) and other potentially deadly bacterial skin infections that have become resistant to older antibiotics.
Dalvance was given priority review and designated a "Qualified Infectious Disease Product" (QIDP) since it is 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 1,289 people with acute bacterial skin infections. The most common side effects noted 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.