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Trius Therapeutics, Inc.
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).
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