FDA Approves First Single-Dose IV Antibiotic to Treat Acute Bacterial Skin Infections

Posted by The Evidence Blog on August 8, 2014

On August 6, 2014, the Food and Drug Administration (FDA) approved Orbactiv (oritavancin) to treat acute bacterial skin and skin structure infection (ABSSSI), a leading cause for U.S. hospital admissions. Common types of ABSSSI include cellulitis, erysipelas, surgical or traumatic wound infection, and major cutaneous abscess.

Orbactiv is an intravenous (IV) “second-generation” glycopeptide antibiotic. It has a prolonged half-life, compared with standard vancomycin. This allows Orbactiv to be given in a 1-dose regimen. Orbactiv is the only antibiotic FDA approved to treat ABSSSIs with a single IV administration. Orbactiv is indicated to treat adults with ABSSSI caused by specified susceptible gram-positive bacteria, including methicillin-resistant Staphylococcus aureus (MRSA).

Three new antibiotics are now FDA approved to treat ABSSSI. In May 2014, the FDA approved Dalvance (dalbavancin; Durata Therapeutics Inc.), an IV antibiotic in the same drug class as Orbactiv. Dalvance is given in 2 doses, spaced 1 week apart. In June 2014, the FDA approved oral and IV Sivextro (tedizolid phosphate; Cubist Pharmaceuticals Inc.). Sivextro is a second-generation oxazolidinone. It is administered once daily for 6 days.

Topics: Hayes Blog

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