FDA Approves The Medicines Company’s Orbactiv

The US Food and Drug Administration (FDA) has approved The Medicines Company’s Orbactiv (oritavancin) for injection for the treatment of adults with acute bacterial skin and skin structure infections (ABSSSIs) caused by susceptible designated Gram-positive bacteria, including methicillin-resistant Staphylococcus aureus (MRSA).

Orbactiv was designated as a Qualified Infectious Disease Product (QIDP) under the Generating Antibiotic Incentives Now (GAIN) Act of 2012. The QIDP designation qualifies the drug for certain incentives related to the development of new antibiotics, including a five-year extension of any non-patent exclusivity period awarded to the drug.

The European Medicines Agency accepted for review the marketing authorization application for Orbactiv, for which the company is seeking approval for the treatment of complicated skin and soft tissue infections. A decision from the European Commission is expected during the first half of 2015.

The Medicines Company, headquartered in Parsippany, New Jersey, focuses on three therapeutic areas: acute cardiovascular care, surgery and perioperative care, and serious infectious disease care. The company operates in the Americas, Europe and the Middle East, and Asia Pacific regions with global centers in and Zurich, Switzerland.

Source: The Medicines Company and FDA

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