Enforcement Report - Week of February 22, 2023
BALTIMORE--(BUSINESS WIRE)--For those striving to manage opioid use disorder, daily, in-person dosing (Directly Observed Therapy, or DOT) is the standard of care. While DOT secures high rates of adherence, it also presents major barriers to access and increased risks. But a new pilot study published in The Journal of Substance Abuse Treatment suggests that technology-enabled remote observation of methadone doses, using asynchronous video DOT, could allow opioid treatment programs to increase methadone adherence, reduce the barriers associated with in-person requirements, and help address the current behavioral health backlog.
Martindale Pharma is recalling the below batch of Methadone 5mg tablets nas a precautionary measure due to the discolouration of the PVdC film inna small number of blister pockets.
Relmada Therapeutics, Inc. (Nasdaq: RLMD), a clinical-stage company developing novel therapies for the treatment of central nervous system (CNS) diseases, today announced the pricing of an offering of 3,333,334 shares of its common stock at a public offering price of $30.00 per share in an underwritten offering. The gross proceeds to Relmada from the offering, before deducting underwriting discounts and commissions and other estimated expenses payable by Relmada, are expected to be $100,000,020. In addition, Relmada has granted the underwriters a 30-day option to purchase up to an additional 500,000 shares of Relmada's common stock at the public offering price, less underwriting discounts and commissions. The offering is expected to close on December 6, 2019, subject to customary closing conditions.
The purpose of this Notice of Amendment is to notify stakeholders that Health Canada has amended Part A of the List of Opioids. A qualifier has been added to the list to exempt buprenorphine and methadone from the patient information handout and warning sticker requirement when these drugs are authorized and used for the treatment of an opioid use disorder.
US WorldMeds today announced that the US Food and Drug Administration (FDA) approved LUCEMYRA (lofexidine) for mitigation of opioid withdrawal symptoms to facilitate abrupt opioid discontinuation in adults. The FDA reviewed LUCEMYRA under Priority Review, which is granted to submissions for medications that would provide significant improvements in the safety or effectiveness of the treatment, diagnosis or prevention of serious conditions.
The FDA is providing preliminary information about the potential for unintended heating and patient injury with use of the Monteris Medical NeuroBlate probe, which is part of the NeuroBlate System, and bringing to your attention a Class I recall for the device. A Class I recall is the most serious type of recall and is issued when use of the device may cause serious injuries or death. Monteris issued three product advisories between October and December 2017, which were part of the Class I recall; however, the FDA has concerns that the information provided by Monteris has not sufficiently mitigated the risk of unintended probe tip heating. We are working with the manufacturer to address these concerns.
BEND, Ore., March 14, 2018 /PRNewswire/ -- BioMauris LLC today announced that its patented software platform has been selected by the state of Iowa to manage all seed-to-sale components of its medical cannabidiol program, including inventory tracking, medical cannabidiol sales, and patient and caregiver registration. Iowa is the first state to adopt a seed-to-sale solution in which the only legalized form of cannabis is medical cannabidiol. BioMauris is the fifth company to have been awarded a contract to manage a statewide cannabis program.
Novartis' take on what to expect as tech transforms healthcare