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2018
09-21
MicuRx Announces Receipt of FDA’s QIDP and Fast Track Designations for Contezolid and Contezolid Acefosamil
2018-09-21
FOSTER CITY, Calif. and SHANGHAI, China – September 21, 2018 – MicuRx Pharmaceuticals, Inc. today announced the receipt of the qualified infectious disease product (QIDP) classification and grant of fast track status by the U.S. Food and Drug Administration (FDA) for contezolid (MRX-I) and its prodrug contezolid acefosamil (MRX-4) for the treatment of acute bacterial skin and skin structure infections (ABSSSI). QIDP designation is granted under the U.S. Generating Antibiotic Incentive Now (GAIN) Act, which is part of the FDA Safety and Innovation Act of 2012 (FDASIA). The Act provides incentives for the development of antimicrobials active against priority bacterial pathogens, and includes Fast Track designation for review and five years of market exclusivity added to any non-patent exclusivity. “MicuRx is proud to have received QIDP and Fast Track designation for our oxazolidinone agents, contezolid and the prodrug contezolid acefosamil,” commented Mike Gordeev, Ph.D., MicuRx’s Chief Scientific Officer. “We believe that this FDA designation affirms the need for new drugs effective against the priority pathogens methicillin-resistant Staphylococcus aureus (MRSA) and vancomycin-resistant Enterococcus (VRE).” Contezolid and contezolid acefosamil are next-generation oxazolidinone agents with notably reduced hematologic toxicity, while maintaining the excellent therapeutic efficacy of the class. Contezolid and contezolid acefosamil are…
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