FDA gives MDCO's ABSSSI drug oritavancin 2nd chance
This article was originally published in Scrip
Executive Summary
If all goes according to schedule, The Medicines Company (MDCO) could have a decision in hand by 6 August for its new drug application (NDA) for oritavancin, an investigational intravenous antibiotic the firm is seeking approval for as a single-dose treatment for acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible gram-positive bacteria, including methicillin-resistant Staphylococcus aureus (MRSA).