Eagle Pharmaceutics Inc. said Wednesday it has won Food and Drug Administration Qualified Infectious Disease Product (QDIP) and Fast-Track Designation for...
Eagle Pharmaceutics Inc.
said Wednesday it has won Food and Drug Administration Qualified Infectious Disease Product and Fast-Track Designation for CAL02, a treatment for severe community-acquired bacterial pneumonia as an add-on therapy to standard of care. The former designation will entitle the company to an additional eight to 10 years of regulatory exclusivity if the product is approved. Eagle also believes CAL02 is a new chemical entity, which would result in five years of marketing exclusivity.
said Wednesday it has won Food and Drug Administration Qualified Infectious Disease Product and Fast-Track Designation for CAL02, a treatment for severe community-acquired bacterial pneumonia as an add-on therapy to standard of care. The former designation will entitle the company to an additional eight to 10 years of regulatory exclusivity if the product is approved. Eagle also believes CAL02 is a new chemical entity, which would result in five years of marketing exclusivity.
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