HealthDay News — The FDA 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. This designation also qualifies the drug for an additional five years of exclusive marketing in addition to certain exclusivity periods.
The drug’s safety and effectiveness were evaluated in clinical studies involving 1,289 people with acute bacterial skin infections. Results indicate the efficacy of Dalvance was similar to vancomycin.
Study participants who took Dalvance also showed a higher-than-expected incidence of elevated liver enzymes in one screening test.
The most common side effects were nausea, headache, and diarrhea, the agency said.
Dalvance is marketed by Durata Therapeutics of Chicago.