FDA Approves The Medicines Company’s OrbactivBy
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 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