Generic Name: dalbavancin
Date of Approval: May 23, 2014
Company: Durata Therapeutics, Inc.

Treatment for: Acute Bacterial Skin and Skin Structure Infections

FDA Approves Dalvance

The U.S. Food and Drug Administration (FDA) has approved Dalvance (dalbavancin), a lipoglycopeptide antibacterial for the treatment of adult patients with acute bacterial skin and skin structure infections (ABSSSI) including those caused by methicillin-resistant Staphylococcus aureus (MRSA).

The U.S. Food and Drug Administration's (FDA) Anti-Infective Drugs Advisory Committee voted unanimously to recommend approval of dalbavancin on March 31, 2014.

Dalvance is administered as a two-dose regimen: the first dose of 1000 mg is followed one week later by 500 mg, each injected as an intravenous infusion over 30 minutes. This dosing schedule provides an alternative to current once-daily or twice-daily treatments and helps reduce, or possibly eliminate, the time patients spend in hospitals by providing an opportunity for care in more convenient and potentially less costly outpatient settings.

Dalbavancin is designated as a Qualified Infectious Disease Product (QIDP) as it is an antibacterial or antifungal human drug intended to treat serious or life-threatening infections. It is the first QIDP to receive FDA approval.

Dalvance should not be used in patients with known hypersensitivity to dalbavancin or other glycopeptide antibiotics including telavancin and vancomycin.

Common side effects seen with treatment were nausea, headache, and diarrhea. Clostridium difficile-associated diarrhea (CDAD) has been reported with nearly all systemic antibacterial agents, including Dalvance. Patients should you should contact their healthcare provider if severe watery or bloody diarrhea develops during treatment.

Dalvance is marketed by Durata Therapeutics, Inc.