ARS Prescribed drugs has introduced their supplemental New Drug Software (sNDA) for a kid dose of neffy has been accepted by the FDA and given precedence assessment.
Neffy is the primary needle-free emergency epinephrine system, FDA-approved to be used in adults and older kids 66 lbs and heavier in August 2024. Fairly than jabbed within the thigh throughout a extreme response, it’s sprayed right into a nostril, thus eliminating the worry of the needle many individuals harbor.
The brand new dose seeks approval for youngsters 33-66 lbs.
As a result of the system was given precedence assessment standing, the FDA set the PDUFA date — the newest date at which they need to determine whether or not to grant approval — at six months reasonably than ten. That date has been set for March 6, 2025.
ARS Pharma can also be planning a dose for infants and toddlers weighing lower than 33 lbs.
To be taught extra about neffy, see this interview with Richard Lowenthal, CEO of ARS Pharma, who solutions your questions concerning the system’s warmth tolerance, time-to-expiration, insurance coverage protection, most out-of-pocket price, and lots of others:
Word of disclosure: ARS Pharma is an advertiser with SnackSafely.com
