Posted by Michael Wonder on 14 Jun 2023
Eagle Pharmaceuticals receives FDA qualified infectious disease product and fast track designation for CAL02
14 June 2023 - With QIDP, Eagle expects to receive eight or ten years of regulatory exclusivity upon NDA approval.
Eagle Pharmaceuticals today announced that the US FDA has granted qualified infectious disease product designation under the Generating Antibiotic Incentives Now (GAIN) Act and fast track designation for CAL02, a first in class non-biological bacterial virulence neutraliser, anti-infective agent being developed to treat severe community-acquired bacterial pneumonia as an add-on therapy to standard of care.
