Eagle pharmaceuticals gets FDA designations as a way to grant it extra exclusivity for ...

Eagle Pharmaceutics Inc. EGRX pointed out Wednesday it has gained meals and Drug Administration qualified Infectious sickness Product (QDIP) and fast-song Designation for CAL02, a remedy for severe neighborhood-acquired bacterial pneumonia (SCABP) as an add-on remedy to normal of care. the previous designation will entitle the company to an extra eight to 10 years of regulatory exclusivity if the product is accepted. Eagle also believes CAL02 is a new chemical entity, which would influence in five years of advertising and marketing exclusivity. The latter underscores the large unmet medical need in treating SCABP, a global disease that...

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