Neuromodulation Device for Depression Granted Designation from FDA

By |2023-03-16T13:04:04-07:00March 16th, 2023|Brief Bulletins from the Field, We Know Psychiatry|

According to published reports, The US Food and Drug Administration (FDA) has granted Breakthrough Device designation to Sooma Medical's portable, noninvasive neuromodulation device for treating depression, which can be administered by the patient. The device, which uses transcranial direct current stimulation to target specific areas of the brain and alleviate [...]

FDA Gives Nod for New High-Dose Naloxone for Opioid Overdose

By |2021-10-18T15:35:46-07:00October 18th, 2021|Brief Bulletins from the Field, We Know Psychiatry|

The US Food and Drug Administration (FDA) has approved a high-dose naloxone injection product for the emergency treatment of opioid overdose. ZIMHI from Adamis Pharmaceuticals is administered using a single-dose, prefilled syringe that delivers 5 mg of naloxone hydrochloride solution through intramuscular or subcutaneous injection. Naloxone is an opioid antagonist [...]

Johnson & Johnson gets FDA nod for twice-yearly schizophrenia drug, Invega Hafyera

By |2021-11-11T16:56:29-08:00September 1st, 2021|Brief Bulletins from the Field, We Know Psychiatry|

Johnson & Johnson thinks a longer-acting treatment against schizophrenia will help keep patients on their prescriptions and reduce their chances of a relapse. Now, with a FDA nod under its belt, the company is pushing Invega Hafyera as just the med to fit the bill. The FDA Wednesday approved J&J’s [...]

FDA Reviewers: Why We Are Against Approval of Aducanumab for Alzheimer’s

By |2021-05-06T09:35:36-07:00May 6th, 2021|Brief Bulletins from the Field, Featured, We Know Psychiatry|

Three members of a US Food and Drug Administration (FDA) advisory committee are explaining why they do not support approval of the drug aducanumab (Biogen, Eisai) for the treatment of Alzheimer's disease (AD). G. Caleb Alexander, MD, Scott Emerson, MD, PhD, and Aaron Kesselheim, MD, JD, MPH, all serve on the [...]

FDA Approves Brexanolone, First Drug for Postpartum Depression

By |2019-03-20T11:48:10-07:00March 20th, 2019|Brief Bulletins from the Field, We Know Psychiatry|

The US Food and Drug Administration (FDA) has approved brexanolone intravenous infusion (Zulresso, Sage Therapeutics), the first-ever drug indicated for the treatment of postpartum depression. The drug is administered under medical supervision as a continuous infusion over a total of 60 hours (2.5 days), according to the FDA. Postpartum depression can [...]

Cassipa Approved by FDA for Opioid Dependence

By |2018-09-12T15:28:07-07:00September 12th, 2018|Brief Bulletins from the Field, We Know Psychiatry|

A new dosage strength of buprenorphine and naloxone sublingual film was approved recently by the Food and Drug Administration. Cassipa sublingual film, made by Teva Pharmaceuticals, is a 16 mg/4 mg dosage of buprenorphine and naloxone for the maintenance treatment of opioid dependence. Buprenorphine and naloxone sublingual film also is [...]

FDA Support for Treating Opioid Addiction With Medication

By |2017-12-06T05:03:22-08:00December 6th, 2017|Brief Bulletins from the Field, We Know Psychiatry|

The FDA plans to convene an expert panel to examine the population-level effects of treating opioid addiction with medication in hopes of gaining wider acceptance of and insurance coverage for those medications. During a late October hearing, FDA Commissioner Scott Gottlieb, MD, told the House Committee on Energy and Commerce [...]

New Buprenorphine Formulation Approved for Medication-Assisted Opioid Treatment

By |2017-12-05T10:29:35-08:00December 5th, 2017|Brief Bulletins from the Field, We Know Psychiatry|

The Food and Drug Administration has approved an extended-release, subcutaneous injection formulation of buprenorphine for use in treating moderate to severe opioid use disorder (OUD), the manufacturer of the drug announced recently. The new product, called Sublocade, is a monthly injection intended for use in patients who have already begun [...]

FDA Approves Vraylar for Schizophrenia in Adults

By |2017-11-30T11:30:29-08:00November 30th, 2017|Brief Bulletins from the Field, We Know Psychiatry|

Allergan plc has announced that the US Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for Vraylar (cariprazine) for the maintenance treatment of adults with schizophrenia. Vraylar is also approved in the US in adults for the acute treatment of schizophrenia and acute treatment of [...]

Digital Tattletales: New Technology Alerts Drug Non-Compliance

By |2021-11-11T17:04:28-08:00November 15th, 2017|Brief Bulletins from the Field, We Know Psychiatry|

The antipsychotic agent, Abilify (aripiprazole, Otsuka), is the first Food and Drug Administration approved digital pill — a medication embedded with a sensor that can tell doctors whether, and when, patients take their medicine. The wearable sensor patch is made by Proteus Digital Health. The approval marks a significant advance in [...]

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