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Furiex Pharmaceuticals, Inc.
FURX announced today that avarofloxacin
(USAN adopted, INN approval pending), has been granted Qualified Infectious
Disease Product (QIDP) and Fast Track designations from the U.S. Food and Drug
Administration (FDA). Avarofloxacin is a Phase III-ready broad-spectrum
fluoroquinolone antibiotic for the treatment of acute bacterial skin and
skin-structure infections, community-acquired pneumonia and has proven to be
effective in treating methicillin-resistant staphylococcus aureus (MRSA)
infections.
The designations should enable Furiex and/or any future collaborator with
respect to the compound to benefit from certain incentives for the development
of new antibiotics, including priority review and additional five-year market
exclusivity, as provided under the Generating Antibiotic Incentives Now (GAIN)
Act, which is incorporated within the FDA Safety and Innovation Act of 2012.
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