BRIXADI

FDA-2024-P-5807 · 4 docket documents

Douglas R. Smith, a concerned medical physician, filed this citizen petition on December 13, 2024, requesting that FDA Commissioner Robert M. Califf immediately enable a Treatment IND and deploy buprenorphine as an antidote to address what the petitioner characterizes as widespread DNA methylation i

FDA-2022-P-1863 · 4 docket documents

The Colorado Society of Addiction Medicine, endorsed by eight other state addiction medicine societies, filed this citizen petition requesting that the FDA update sublingual buprenorphine product labeling to reflect evidence supporting doses greater than 16 mg per day for treating opioid use disorde

FDA-2019-P-1679 · 27 docket documents

Goodwin Procter LLP, on behalf of Braeburn, Inc., filed this citizen petition requesting the FDA revoke the orphan drug designation for Sublocade (buprenorphine extended-release) injection for treatment of opioid use disorder, arguing that the drug affects millions of patients and is expected to gen

FDA-2017-P-5370 · 13 docket documents

Dennis Ryll filed this citizen petition requesting that the FDA amend black box warnings on all Schedule II opioid analgesics (such as morphine, hydrocodone, and oxycodone) to warn prescribers and patients that Schedule III opioids like buprenorphine carry significantly lower risks of addiction and

FDA-2017-P-2230 · 3 docket documents

Purdue Pharma L.P. filed this citizen petition through counsel Kleinfeld, Kaplan and Becker, LLP on April 10, 2017, requesting that the FDA ensure follow-on products citing BUTRANS (buprenorphine) Transdermal System as the reference listed drug under sections 505(j) or 505(b)(2) contain appropriate

FDA-2014-P-0205 · 4 docket documents

Purdue Pharma LP filed this citizen petition requesting that the FDA exercise its authority under Section 505(o) of the Federal Food, Drug and Cosmetic Act to impose safety labeling changes on immediate-release opioid analgesics parallel to those mandated for extended-release and long-acting opioid

FDA-2013-P-0995 · 3 docket documents

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-2012-P-1028 · 5 docket documents

Reckitt Benckiser Pharmaceuticals Inc. filed this petition on September 25, 2012, pursuant to sections 505(b), 505(j), and 505(q) of the Federal Food, Drug, and Cosmetic Act, requesting that the FDA refrain from approving any buprenorphine NDA or ANDA for opioid dependence treatment unless the appli

FDA-2012-P-1034 · 5 docket documents

Lachman Consultant Services, Inc., on behalf of a client, filed this citizen petition requesting that the FDA determine whether SUBOXONE Sublingual Tablets (buprenorphine hydrochloride and naloxone hydrochloride) 2 mg/0.5 mg and 8 mg/2 mg, approved under NDA 20-733, were voluntarily withdrawn from s

FDA-2011-P-0869 · 5 docket documents

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 · 4 docket documents

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-0446 · 16 docket documents

Virginia Commonwealth University's Institute for Drug and Alcohol Studies filed this citizen petition under 21 CFR 10.30 and Section 505(q) requesting that the FDA Commissioner modify labeling for all buprenorphine HCl products to restrict buprenorphine-only formulations to pregnant women and patien

FDA-2009-P-0325 · 6 docket documents

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