FDA approval of dalvance in the treatment of skin infection

Source: on May 26, 2014, the food and Drug Administration of the United States approved a new antibacterial drug dalvancin to treat adult skin infection Dalvance can treat acute bacterial skin and skin structural infections (absssi) caused by some susceptible bacteria such as Staphylococcus aureus (including methicillin sensitive and methicillin resistant strains) and Streptococcus pyogenes The treatment was intravenous administration Dalvance is the first drug approved by FDA as qualified infectious disease product (qidp) According to the antibiotic incentive program (gain) in the FDA safety innovation act, dalvance was awarded the title of qidp product as an antibacterial or antifungal drug used to treat serious or life-threatening infections "Today's approval demonstrates FDA's commitment to promote the development and approval of new antimicrobial drugs, and dalvance's approval provides doctors and patients with important new treatment options," said Edward Cox, MD, m.p.h., director of the antimicrobial products office of the FDA Center for drug evaluation and research As part of its qidp determination, dalvance received a priority review Dalvance's qidp certification also gives it a five-year market monopoly under the food, drug and Cosmetics Act Two clinical trials involving 1289 adult absssi patients evaluated the safety and efficacy of dalvance Participants were randomly assigned to receive dalvance or another antibiotic, vancomycin The results showed that dalvance was as effective as vancomycin in the treatment of absssi The most common adverse reactions found in clinical trials were nausea, headache and diarrhea In this trial, more participants in the dalvance group had an elevated liver enzyme test Dalvance's drug label advises patients with renal insufficiency to adjust their dosage Dalvance is marketed by Chicago based Durata therapeutics Original link: http://