Abuse-Deterrent Opioid Analgesics | FDA

Generic Opioids with FDA-Approved Labeling Describing Abuse-Deterrent Properties FDA has approved the following generic opioid(s) with abuse-deterrent properties consistent with the FDA’s Guidance for Industry: General Principles for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products: How does the FDA decide what drugs are considered abuse-deterrent? To meet the FDA’s standards, it is essential that every opioid with labeling describing its abuse-deterrent properties be grounded in science and supported by evidence. ...

Use of prescription opioids with abuse-deterrent technology to address opioid ab

Some patients switched to other ER/LA opioids without abuse-deterrent technology or discontinued ER/LA opioid treatment when their existing ER treatment was reformulated. Rates of opioid abuse were...

Adverse health effects of abuse-deterrent opioids: Evidence from the reformulati

In response, pharmaceutical companies have begun introducing abuse-deterrent painkillers, pills with properties that make the drug more difficult to misuse. The first such painkiller, a...

Opioid Medications | FDA

FDA takes actions to combat prescription opioid abuse. Prescription opioids are powerful pain-reducing medications that include prescription oxycodone, hydrocodone and morphine. These medications c...

Abuse-deterrent opioids: an update on current approaches and considerations: Current Medical Research and....

Methods: A PubMed search was performed for articles published within the last 10 years using the search terms “abuse deterrent opioids”. Articles were limited to clinical studies and...

Abuse-Deterrent Opioids-Evaluation and Labeling | FDA

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5)) ; If unable to submit comments online, please mail written comments to: ; Dockets Management Food and Drug Administration 5630 Fishers Lane, Rm 1061 Rockville, MD 20852 ; All written comments should be identified with this document's docket number: FDA-2013-D-0045.

Abuse-Deterrent Opioids — Evaluation and Labeling

Abuse-Deterrent Opioids — Evaluation and Labeling Guidance for Industry U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research...

Abuse-Deterrent Opioids and the Law of Unintended Consequences

ADFs have encouraged users to switch to more dangerous opioids, including illegal heroin. In... Like the federal government’s promotion of abuse‐deterrent alcohol a century ago, these...

Effect of Abuse-Deterrent Formulation of OxyContin | New England Journal of Medicine

In 2010, an abuse-deterrent formulation of the widely abused prescription opioid OxyContin replaced the original formulation. After the new formulation was introduced, patients reported that they u...

Cato Institute Urges FDA, HHS To Stop Promotion Of Abuse-Deterrent Opioids

저자 : Wang, Beth, 수록출판물 : InsideHealthPolicy.com's FDA Week, 2017 Dec 01. 23(48), 5-6. 발행연도 : 2017, 언어 : English, ISSN : 21654166, 데이터베이스 : JSTOR Journals, 등록번호 : edsjsr.26704919, 문서유형 : research-article, 원문URL : https://www.jstor.org/stable/26704919