Posted by: nyguy
« on: July 27, 2017, 09:57:49 AM »Press Release:
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.
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.