Kaléo announced FDA granted Priority Review of their epinephrine auto-injector

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Kaléo announced the FDA granted Priority Review of their epinephrine auto-injector designed to treat allergic reactions in infants and small children

Kaléo, a privately-held pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has granted Priority Review of its supplemental New Drug Application (sNDA) for AUVI-Q 0.1 mg, the first known epinephrine auto-injector specifically designed for the treatment of life-threatening allergic reactions in infants and small children weighing 16.5 to 33 pounds. The new 0.1 mg dose epinephrine auto-injector has a shorter needle length and lower dose than existing 0.15 mg and 0.3 mg epinephrine auto-injectors.

Priority Review designation by the FDA is given to drugs that, if approved, may provide significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to available therapies.

 

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