Rib-X Pharmaceuticals, Inc. Receives Qualified Infectious Disease Product (QIDP) Designation From the FDA for Delafloxacin
9/17/2012 9:11:03 AM
NEW HAVEN, Conn.--(BUSINESS WIRE)--Rib-X Pharmaceuticals, Inc., today announced that the Food and Drug Administration (FDA) designated delafloxacin as a Qualified Infectious Disease Product (QIDP) for the indications of acute bacterial skin and skin structure infections (ABSSSI) and community-acquired bacterial pneumonia (CABP). The QIDP designation will enable Rib-X to benefit from certain incentives for the development of new antibiotics, including an additional five years of market exclusivity, priority review and eligibility for fast-track status, provided under the new Generating Antibiotic Incentives Now (GAIN) program. GAIN was included in the FDA Safety and Innovation Act (FDASIA), formerly known as PDUFA V, which received bipartisan Congressional support and was signed into law by President Obama in July 2012.