Trials & Filings

TMC Antibiotic Gets QIDP Status

Carbavance entering Ph II in 2014

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

The FDA has designated The Medicines Company‘s Carbavance as a Qualified Infectious Disease Product (QIDP). This designation provides Carbavance priority review by the FDA, eligibility for Fast Track status, and an additional five years of exclusivity upon approval of the product for intravenous use in six indications. These include complicated urinary tract and intra-abdominal infections, hospital-acquired bacterial pneumonia/ventilator-associated bacterial pneumonia, and febrile neutrope...

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