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Author Topic: Kaléo granted priority review for Auvi-Q injector for infants/smaller children  (Read 161 times)

Description: 0.1mg dosage, smaller needle

Offline nyguy

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Press Release:

Quote
RICHMOND, Va., July 27, 2017 /PRNewswire/ -- 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.


Kind of surprised if this is a growing issue that Mylan et al haven't moved in, but interesting none the less. Estimated availability is the first half of 2018 if approved by FDA.