Furiex Wins Fast Track Designations for Avarofloxacin
Furiex Pharmaceuticals, Inc. (NASDAQ: 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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