FDA accepts NDA for Targanta's oritavancin

The US Food and Drug Administration has accepted for standard review a New Drug Application for USA-based Targanta's lead antibiotic candidate, oritavancin, setting a target date to act on the NDA filing by December 8. The oritavancin NDA was submitted in early February seeking approval of the intravenous antibiotic for the treatment of complicated skin and skin structure infections caused by gram-positive organisms, including methicillin-resistant Staphylococcus aureus. These types of resistant infections have created a market that IMS Health estimates to be over $1.0 billion dollars in the USA in 2007 and growing rapidly.

"With an expected FDA response date in December, we have begun the exciting task of building a commercial infrastructure to position the company to begin marketing oritavancin in the USA in the first half of 2009," said Mark Leuchtenberger, chief executive of the firm. In addition, he added that Targanta is on track to submit a Marketing Authorization Application for European Union approval of oritavancin by mid-2008 for the treatment of complicated skin and soft tissue infections.