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Third gram positive agent approved in last 6 months

07 Aug 2014 8:34 AM | Christopher McCoy

After initial rejection in 2008, Oritavancin is approved today with the gateway indication for acute bacterial skin and skin structure infections (ABSSSI) caused by certain susceptible bacteria, including Staphylococcus aureus (including methicillin-susceptible and methicillin-resistant strains), various Streptococcus species and Enterococcus faecalis.  Oritavancin now joins dalbavancin, approved May 2014 and tedizolid approved June 2014 for similar indications, all with unique profiles.  The data exceeds this space so for more information, you can always review the CDER brief but objective review for dalbavancin and tedizolid. Review papers from the 2000s for oritavancin basics. Three new drugs courtesy of the GAIN act. Looking forward to the new beta lactamase inhibitor and cephalosporin for new gram negative pathogen options.


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