--- title: Reviewing Significant FDA Psychiatry Approvals in 2025 description: From January's approval of a novel non-opioid pain medication through December's approval of the first at-home device for depression treatment, the psychiatry field saw many notable approvals and clearances this past year. image: https://alert.psychnews.org/hubfs/Imported_Blog_Media/fda_building_iStock-1286971245-Jun-24-2025-10-30-30-4671-PM.jpg --- 12/29/25 11:00 AM # Reviewing Significant FDA Psychiatry Approvals in 2025 ![Picture of Psychiatric News Alert](https://alert.psychnews.org/hs-fs/hubfs/Psych%20News%20Email%20Banners/PN-Blue-Box_rgb.png?width=50&name=PN-Blue-Box_rgb.png) [ Psychiatric News Alert ](https://alert.psychnews.org/author/psychiatric-news-alert) Share: [facebook-f icon ](http://www.facebook.com/share.php?u=https://alert.psychnews.org/reviewing-significant-fda-psychiatry-approvals-in-2025) [linkedin-in icon ](http://www.linkedin.com/shareArticle?mini=true&url=https://alert.psychnews.org/reviewing-significant-fda-psychiatry-approvals-in-2025) [Twitter icon ](https://twitter.com/intent/tweet?url=https://alert.psychnews.org/reviewing-significant-fda-psychiatry-approvals-in-2025) [pinterest-p icon ](http://pinterest.com/pin/create/link/?url=https://alert.psychnews.org/reviewing-significant-fda-psychiatry-approvals-in-2025) [envelope icon ](mailto:?body=https://alert.psychnews.org/reviewing-significant-fda-psychiatry-approvals-in-2025) **![fda_building_iStock-1286971245-Jun-24-2025-10-30-30-4671-PM](https://alert.psychnews.org/hs-fs/hubfs/Imported_Blog_Media/fda_building_iStock-1286971245-Jun-24-2025-10-30-30-4671-PM.jpg?width=220&height=146&name=fda_building_iStock-1286971245-Jun-24-2025-10-30-30-4671-PM.jpg)January **The FDA approves the esketamine nasal spray **[Spravato](https://www.jnjlabels.com/package-insert/product-monograph/prescribing-information/SPRAVATO-pi.pdf)** as a monotherapy for adults with treatment-resistant depression. Spravato had been previously approved for use alongside an oral antidepressant.   The FDA approves the sodium channel blocker **[Journavx (suzetrigine)](https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/219209s000lbl.pdf)** for treatment of moderate to severe acute pain in adults.   **February **The FDA approves **[Onapgo](https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/214056s000lbl.pdf)**, a subcutaneous infusion formulation of the dopamine agonist apomorphine, for treatment of motor problems in adults with advanced Parkinson’s disease.   **March** The FDA expands the clearance of the **[Horizon Inspire and 3.0 Transcranial Magnetic Stimulation (TMS) systems](https://www.accessdata.fda.gov/cdrh_docs/pdf24/K243869.pdf)**, now making them available as adjunct therapies for adolescents aged 15 to 21 with major depressive disorder.   **April **The FDA approves **[Mezofy](https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/211448s000lbl.pdf)**, an oral film formulation of aripiprazole, for the treatment of schizophrenia in patients ages 13 and older.   The FDA expands the marketing clearance for **[Freespira](https://freespira.com/teens/)**—an at-home prescription treatment device for panic attacks and posttraumatic stress disorder—to include adolescents ages 13 to 17.   **May **The FDA clears the **[Lumipulse G pTau217/β-Amyloid 1-42 Plasma Ratio](https://www.fujirebio.com/en-us/products-solutions/lumipulser-g-ptau-217bamyloid-142-plasma-ratio)**—the first blood test for use in the assessment of potential Alzheimer’s disease. The Lumipulse is intended for adults ages 55 and older presenting at a specialized care clinic with signs and symptoms of cognitive decline.   **June **The FDA approves **[Arynta](https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/219847s000lbl.pdf)**, an oral solution of the stimulant lisdexamfetamine, for treatment of ADHD and binge eating disorder in patients ages 6 and older.   **August **FDA approves **[Tonmya (cyclobenzaprine hydrochloride)](https://www.tonixpharma.com/wp-content/uploads/2025/08/Tonmya-Prescribing-Information.pdf)** sublingual tablets for the treatment of fibromyalgia in adults.   The FDA approves **[Leqembi IQLIK](https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761375s000lbl.pdf)**, a weekly, at-home subcutaneous autoinjector of lecanemab, for individuals with early Alzheimer’s disease who have completed an 18-month regimen of intravenous lecanemab.   The FDA grants an expansion for the **[MagVenture TMS Therapy](https://www.accessdata.fda.gov/cdrh_docs/pdf25/K251125.pdf)** system as an adjunct in adolescents ages 15 to 21 with major depressive disorder.   **September **The FDA approves **[Subvenite](https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/218879s000lbl.pdf)**, an oral suspension of the anticonvulsant lamotrigine, for the treatment of epilepsy and bipolar disorder.   **October **The FDA clears another blood test to aid in the assessment for Alzheimer’s disease—the **[Elecsys pTau181](https://diagnostics.roche.com/us/en/products/lab/elecsys-phospho-tau-181p-plasma-pid00001042.html)****[Test](https://diagnostics.roche.com/us/en/products/lab/elecsys-phospho-tau-181p-plasma-pid00001042.html)**. It’s also intended for patients ages 55 and older presenting with signs, symptoms, or complaints of cognitive decline, but may be used in primary care settings.   The FDA approves the use of **[Uzedy](https://www.uzedy.com/globalassets/uzedy/prescribing-information.pdf)**, a long-acting injectable of risperidone, as a monotherapy or adjunctive therapy to lithium or valproate for the maintenance treatment of bipolar I disorder in adults.   **November **The FDA adds another indication for **[Caplyta (lumateperone)](https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/209500s016lbl.pdf)**, approving the second-generation antipsychotic as an adjunct to antidepressant therapy for adults with major depressive disorder.   The FDA clears the **[Deep TMS](https://510k.innolitics.com/device/K251391)** system for use as an adjunct therapy for adolescents ages 15 to 21 with major depressive disorder.   **December** The FDA clears a prescription version of the Lumosity brain training platform; the **[LumosityRx](https://www.lumosity.com/en/rx/)** app is authorized for adults ages 22 to 55 with ADHD.   The FDA clears the **[Fl-100](https://www.accessdata.fda.gov/cdrh_docs/pdf23/P230024B.pdf)**, an at-home transcranial direct current stimulation device, for the treatment of moderate to severe major depressive disorder.   (Image: Getty Images/iStock/Grandbrothers)   [medication](https://alert.psychnews.org/tag/medication), [TMS](https://alert.psychnews.org/tag/tms), [FDA](https://alert.psychnews.org/tag/fda), [Food and Drug Administration](https://alert.psychnews.org/tag/food-and-drug-administration), [clearance](https://alert.psychnews.org/tag/clearance), [Lumosity](https://alert.psychnews.org/tag/lumosity), [approvals](https://alert.psychnews.org/tag/approvals), [medical device](https://alert.psychnews.org/tag/medical-device) ## Related Posts [![](https://alert.psychnews.org/hs-fs/hubfs/Imported_Blog_Media/fda_building_iStock-1213293784-Jun-24-2025-06-30-38-1020-PM.jpg?height=200&name=fda_building_iStock-1213293784-Jun-24-2025-06-30-38-1020-PM.jpg) ](https://alert.psychnews.org/2024/12/reviewing-fdas-major-psychiatry.html) ## [Reviewing the FDA’s Major Psychiatry Approvals in 2024](https://alert.psychnews.org/2024/12/reviewing-fdas-major-psychiatry.html) 12/27/24 12:00 AM [ Read more ](https://alert.psychnews.org/2024/12/reviewing-fdas-major-psychiatry.html) [![](https://alert.psychnews.org/hs-fs/hubfs/Imported_Blog_Media/PET_iStock-480338933-Jun-24-2025-06-34-42-4754-PM.jpg?height=200&name=PET_iStock-480338933-Jun-24-2025-06-34-42-4754-PM.jpg) ](https://alert.psychnews.org/2021/06/alzheimers-antibody-therapy-receives.html) ## [Alzheimer’s Antibody Therapy Receives Accelerated Approval Amid Controversy](https://alert.psychnews.org/2021/06/alzheimers-antibody-therapy-receives.html) 6/8/21 12:00 AM [ Read more ](https://alert.psychnews.org/2021/06/alzheimers-antibody-therapy-receives.html) [![](https://alert.psychnews.org/hs-fs/hubfs/Imported_Blog_Media/FDA_NewLogo-Jun-24-2025-04-38-24-6131-PM.jpg?height=200&name=FDA_NewLogo-Jun-24-2025-04-38-24-6131-PM.jpg) ](https://alert.psychnews.org/2018/05/first-non-opioid-medication-approved-to.html) ## [First Non-Opioid Medication Approved to Reduce Opioid Withdrawal Symptoms in Adults](https://alert.psychnews.org/2018/05/first-non-opioid-medication-approved-to.html) 5/17/18 12:00 AM [ Read more ](https://alert.psychnews.org/2018/05/first-non-opioid-medication-approved-to.html) ```json { "@context" : "https://schema.org", "@type" : "BlogPosting", "author" : { "@type" : "Person", "name" : "Psychiatric News Alert", "url" : "https://alert.psychnews.org/author/psychiatric-news-alert" }, "dateModified" : "2025-12-29T16:00:00.248Z", "datePublished" : "2025-12-29T16:00:00.000Z", "headline" : "Reviewing Significant FDA Psychiatry Approvals in 2025", "image" : [ "https://alert.psychnews.org/hubfs/Imported_Blog_Media/fda_building_iStock-1286971245-Jun-24-2025-10-30-30-4671-PM.jpg" ], "mainEntityOfPage" : { "@id" : "https://alert.psychnews.org/reviewing-significant-fda-psychiatry-approvals-in-2025", "@type" : "WebPage" }, "publisher" : { "@type" : "Organization", "logo" : { "@type" : "ImageObject", "url" : "https://alert.psychnews.org/hubfs/PN-Blue-Box.jpg" } } } ```