NALOXONE

FDA-2021-P-0514

Hyman, Phelps & McNamara P.C. filed a citizen petition regarding Narcan requesting that the FDA determine the suitability of the drug product for over-the-counter use, which involves evaluating whether the product can be safely and effectively used by consumers without professional supervision.

FDA-2021-P-0514

The law firm Hyman, Phelps & McNamara P.C. filed a petition regarding NARCAN (naloxone) and its prescribing information suitability. The petition seeks FDA action on matters related to NARCAN's product information and labeling, though the specific requested regulatory action is not detailed in this

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-2016-P-1090

Lachman Consultant Services, Inc., on behalf of Adapt Pharma Ltd., filed this citizen petition on March 24, 2016, requesting that the FDA require prescribing information updates for prescription opioids and medically assisted therapy products to recommend naloxone co-prescribing and mandate updates

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

FDA-2013-P-0995

Hyman, Phelps & McNamara, P.C. filed this Section 505(q) citizen petition requesting that FDA refuse to file any 505(b)(2) NDA for a buprenorphine/naloxone buccal polymer film product unless it references NDA No. 22-410 for SUBOXONE sublingual film as the listed drug and makes appropriate patent cer

FDA-2011-P-0869

Hyman, Phelps & McNamara, P.C., on behalf of the holder of NDA #22-410 for SUBOXONE sublingual film, petitioned the FDA to refuse to file any 505(b)(2) NDA for a buprenorphine/naloxone polymer film product for oral mucosal application unless the applicant references NDA #22-410 rather than the table

FDA-2009-P-0459

Aerscher LLC filed a citizen petition under Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting FDA permission to submit an ANDA for buprenorphine hydrochloride 8mg combined with naloxone hydrochloride 2mg in an orally soluble strip format marketed as Buprox, which differs fr

FDA-2009-P-0325

Reckitt Benckiser Pharmaceuticals Inc. filed this citizen petition pursuant to Sections 505(j) and 505(q) of the Federal Food, Drug, and Cosmetic Act requesting that FDA require generic applicants submitting ANDAs and 505(b)(2) NDAs for Subutex (buprenorphine) and Suboxone (buprenorphine/naloxone) s