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    Tag: fda

    FDA Eliminates Clozapine REMS Program: What This Means for Patients and Prescribers

    In a major regulatory update, the U.S. Food and Drug Administration (FDA) has announced the discontinuation of the Risk Evaluation and Mitigation Strategy (REMS) program…

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    Dr. Harvinder Singh February 25, 2025

    FDA Approved Cobenfy: Non-Dopaminergic Treatment for Schizophrenia

    In a significant development for the treatment of schizophrenia, the FDA has recently approved Cobenfy, a novel medication that targets schizophrenia through non-dopaminergic pathways. This…

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    Dr. Harvinder Singh September 29, 2024

    Iloperidone: New FDA Approval for Bipolar 1 Disorder

    In a significant stride forward in mental health treatment, the Food and Drug Administration (FDA) has recently approved Iloperidone for the management of bipolar disorder.…

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    Dr. Harvinder Singh April 7, 2024

    Gepirone (Exxua): New Antidepressant FDA Approved for MDD

    On Sep 28, 2023: Fabre-Kramer Pharmaceuticals Announcesd the FDA Approval of EXXUA™, the Oral Selective 5HT1a Receptor Agonist for the Treatment of Major Depressive Disorder…

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    Dr. Harvinder Singh September 30, 2023

    Auvelity: New Oral Fast Acting FDA Approved Antidepressant

    On Aug 19, 2022 Axsome Therapeutics announced the FDA Approval of Auvelity, as the first and Only Oral NMDA Receptor Antagonist for the treatment of…

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    Dr. Harvinder Singh August 22, 2022

    Viloxazine: Non-Stimulant Medication now FDA Approved for Adult ADHD

    Viloxazine ER (Qelbree) was initially approved for pediatric ADHD and now had received FDA approval for the management of ADHD in adult patients. We have…

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    Dr. Harvinder Singh May 2, 2022

    IGALMI™ (Dexmedetomidine): First Sublingual Medication FDA Approved for Acute Agitation

    Today FDA has approved the first sublingual medication, IGALMI (Dexmedetomidine) for the management of acute agitation in indications discussed below. We have summarized this medication…

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    Dr. Harvinder Singh April 6, 2022

    New Sleep Medication Approved: Daridorexant (Quviviq)

    On Jan 10, 2022, FDA has approved this new medication for treatment of adults with insomnia: Quviviq (daridorexant). This FDA approval is based on the…

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    Dr. Harvinder Singh January 11, 2022

    Invega Hafyera™ (6-monthly paliperidone palmitate): FDA Approved for Schizophrenia

    Sep 01, 2021. Today FDA approved the first and only 6 monthly long-acting injectable for schizophrenia treatment: Invega Hafyera. We have summarized Invega Hafyera clinical…

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    Dr. Harvinder Singh September 1, 2021

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