FDA grants QIDP and Fast Track designations to TaiGen's nemonoxacin

Published on December 23, 2013 at 3:39 AM · No Comments

TaiGen Biotechnology Company, Limited ("TaiGen") today announced that the U.S. Food and Drug Administration (FDA) has granted nemonoxacin (Taigexyn®) Qualified Infectious Disease Product (QIDP) and Fast Track designations for community-acquired bacterial pneumonia (CAP) and acute bacterial skin and skin structure infections (ABSSSI). These two designations should enable TaiGen and/or its partners to benefit from certain incentives for the development of nemonoxacin as a new antibiotic, including an additional five year extension to new chemical entity (NCE) market exclusivity, priority review, and fast track status provided under the Generating Antibiotic Incentives Now (GAIN) act. GAIN was included in the FDA Safety and Innovation Act (FDASIA) that was signed into law by US President Obama in 2012.

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