NALOXONE

FDA-2021-P-0514

Hyman, Phelps & McNamara P.C. filed a citizen petition regarding the prescribing information for naloxone nasal spray, specifically addressing suitability matters related to the product. The petition requests FDA action on the product information labeling for this naloxone formulation.

FDA-2016-P-2072

Pacific-Link Consulting on behalf of Adapt Pharma filed this citizen petition on July 11, 2016, requesting that the FDA establish guidelines defining the optimal fixed initial dose, required pharmacokinetic exposure levels including time to onset and duration of effect, and device requirements for a

FDA-2016-P-1875

Pacific-Link Consulting, representing Adapt Pharma Limited, filed this citizen petition on June 29, 2016, requesting that the FDA establish guidelines for optimal dosing and pharmacokinetic exposure levels for naloxone-containing products intended for emergency treatment of suspected opioid overdose

FDA-2014-P-0752

Pharmacists Planning Service, Inc. (PPSI), a nonprofit public health organization, filed this citizen petition under 21 CFR 10.20 and 10.30 requesting that the FDA Commissioner issue a federal regulation to make naloxone, whether injected or administered nasally to reverse opioid overdoses, availabl