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: