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Trius Therapeutics Receives QIDP Designation from FDA

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Trius Therapeutics, Inc. (Nasdaq: TSRX), a biopharmaceutical company focused on the discovery and development of innovative antibiotics for serious infections, announced today that the U.S. Food and Drug Administration (FDA) has designated the company's Phase 3 antibiotic candidate, tedizolid phosphate, as a Qualified Infectious Disease Product (QIDP). Trius received the designation for its current Phase 3 program of tedizolid for acute bacterial skin and skin structure infections (ABSSSI) as well as the planned Phase 3 program for hospital-acquired/ventilator-associated bacterial pneumonia (HABP/VABP). In addition, the designations were granted for both the intravenous and oral dosage forms of tedizolid. The QIDP designation will enable Trius to benefit from certain incentives for the development of new antibiotics, including priority review and eligibility for fast-track status. The QIDP designation was created by the Generating Antibiotic Incentives Now (GAIN) Act, which was part of the FDA Safety and Innovation Act (FDASIA).

Posted-In: News FDA


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