Request that the FDA to (i) require proposed generic versions of Intranasal (IN) naloxone products to provide specific pharmacokinetic (PK), device, stability and Chemistry, Manufacturing and Controls (CMC) data, as set-out herein, within the ANDA, to support the interchangeability of generic IN naloxone and the IN naloxone Reference Listed Drug (RLD); (ii) not to approve any
Citizen Petition CDER 2016-6877 OPNE Adapt Pharma Operations Ltd Intranasal naloxone products pharmacokinetic device, stability and Chemistry Manufacturing and Controls interchangeability of generic IN naloxone and the IN naloxone
2017-05-30
FDA-2016-P-4094-0004
04:00:00
https://api.regulations.gov/v4/comments/FDA-2016-P-4094-0004
Anonymous
Anonymous
See uploaded file. 