The Medicines Company re-files oritavancin at FDA for ABSSSI infections caused by MRSA.
The FDA has accepted the re filed application for oritavancin from The Medicines Company. The company is hoping to get the drug approved for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible gram-positive bacteria, including methicillin-resistant Staphylococcus aureus (MRSA), administered as a single dose.
The FDA has designated oritavancin as a Qualified Infectious Disease Product (QIDP), which means a priority review as well as an additional five years of exclusivity upon approval of the drug.
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