By granting standard review status to oritavancin, the FDA has established a target date to act on the new drug application (NDA) filing by December 8, 2008. The oritavancin NDA was submitted in early February seeking approval of the intravenous antibiotic for the treatment of complicated skin and skin structure infections (cSSSI) caused by gram-positive organisms, including methicillin-resistant Staphylococcus aureus.
Mark Leuchtenberger, president and CEO of Targanta, said: “We are on track to submit a marketing authorization application for EU approval of oritavancin by mid-2008 for the treatment of complicated skin and soft tissue infections, the European name for cSSSI, and, given our preliminary discussions with EU regulatory authorities and standard review times, we hope to receive approval of oritavancin in the EU in late 2009.”