Why is agomelatine not approved in USA?

Agomelatine is not approved for use in the United States by the Food and Drug Administration (FDA). The reasons for this are not entirely clear, but it may be related to concerns about the safety and efficacy of the medication.

One potential reason for agomelatine not being approved in the United States is that the FDA has more stringent requirements for the approval of new medications than regulatory agencies in other countries. In addition, there may be concerns about the safety and efficacy of agomelatine based on clinical trial data.

Another potential reason is that there may not be a significant market for agomelatine in the United States, as there are many other antidepressant medications available that are approved by the FDA and are widely used.

It is important to note that while agomelatine is not approved for use in the United States, it is approved for use in other countries and may be prescribed by healthcare providers in those countries. As with any medication, it is important to discuss potential benefits and risks with a healthcare provider before starting treatment with agomelatine.


There are various forms of drugs available, such as tablets or liquids, and each may have a separate patient information leaflet (PIL) for different doses. It is important to refer to the PIL for the specific form and dose of the drug that you have been prescribed.

You can search for further information and PILs on websites such as:

  • The British National Formulary (BNF)
  • Electronic medicines compendium (emc)
  • The National Library of Medicine's DailyMed
  • The Food and Drug Administration (FDA) 
  • Different drug forms like tablets or liquids have specific patient information leaflets (PIL) for various doses. Refer to the PIL for your prescribed drug form and dose.

    Search for PILs on websites like:

    France

    • ANSM (Agence nationale de sécurité du médicament et des produits de santé): ansm.sante.fr

    Spain

    • AEMPS (Agencia Española de Medicamentos y Productos Sanitarios): aemps.gob.es

    Germany

    • BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte): bfarm.de

    Italy

    For questions about your medication:

    • Consult your doctor, a healthcare professional, or a pharmacist

    France

    • Contact SOS Médecins: 3624
    • For mental health support, contact SOS Suicide: 01 45 39 40 00

    Belgium (French)

    Switzerland (French)

    • La Main Tendue: 143
    • Website: 143.ch

    Canada (French)

    • Centre de prévention du suicide du Québec: 1 866 APPELLE (1 866 277-3553)
    • Website: cpsquebec.ca

    Spain

    • Contact emergency number: 112
    • For mental health support, contact Teléfono de la Esperanza: 717 003 717

    Germany

    • Contact emergency number: 112
    • For mental health support, contact Telefonseelsorge: 0800 111 0 111 or 0800 111 0 222

    Italy

    • Contact emergency number: 112
    • For mental health support, contact Telefono Amico: 199 284 284

    Netherlands

    • Contact emergency number: 112
    • For mental health support, contact 113 Zelfmoordpreventie: 0800 0113

    Portugal

    • Contact emergency number: 112
    • For mental health support, contact Sos Voz Amiga: 21 354 45 45, 91 280 26 69, or 96 352 46 60

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