Kaléo granted priority review for Auvi-Q injector for infants/smaller children

Started by nyguy, July 27, 2017, 09:57:49 AM

Previous topic - Next topic

nyguy

Press Release:

QuoteRICHMOND, 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.

Quick Reply

Warning: this topic has not been posted in for at least 365 days.
Unless you're sure you want to reply, please consider starting a new topic.

Name:
Email:
Verification:
Please leave this box empty:
Type the letters shown in the picture
Listen to the letters / Request another image

Type the letters shown in the picture:
Spell the answer to 6 + 7 =:
Three blonde, blue-eyed siblings are named Suzy, Jack and Bill.  What color hair does the sister have?:
Shortcuts: ALT+S post or ALT+P preview