Trials & Filings

TMC’s ABSSSI NDA Gets QIDP

Benefits from Generating Antibiotic Incentives Now program

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

The FDA has granted The Medicines Company Qualified Infectious Disease Product (QIDP) status for oritavancin. This designation provides oritavancin priority review by the FDA, eligibility for FDA’s Fast Track status, and an additional five years of exclusivity upon approval of the product for the treatment of acute bacterial skin and skin structure infections (ABSSSI). The Medicines Company plans to submit a New Drug Application to the FDA in 4Q13 for the use of oritavancin in ABSSSI caus...

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