This article is about FDA approved cannabis-derived products.
The FDA has approved one cannabis-derived product and three cannabis-related products. There are other cannabis-related medications outside the US.
Medications that the FDA approved in the US might not be approved in the EU. Even if one EU country approved certain medications, other EU countries or the US may not have approved them.
However, the FDA has not approved cannabis, as a plant, for the treatment of any condition or disease.
We are discussing the following topics:
The FDA has approved one cannabis-derived product:
Epidiolex is a prescription medicine to treat seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in patients 2 years of age and older.
The FDA has approved three cannabis-related products:
Marinol and Syndros are prescription medicines to treat anorexia in people with AIDS who have lost weight and to treat nausea and vomiting caused by chemotherapy in cancer patients.
Cesamet is a prescription medicine to treat nausea and vomiting associated with chemotherapy in cancer patients.
Based on scientific information makers of the drugs have provided to the agency, the FDA concluded that the above drugs are effective medicines for their intended uses, and they are also safe to use.
Cannabis-related medications that are approved in Europe, but not in the US are:
Currently there are no cannabis-related medications centrally (EMA) approved in all EU countries. Only certain EU countries authorized the above medications.
Apart from Epidiolex, Marinol, Syndros, and Cesamet, there are no other FDA- or EU regulatory-approved drugs that contain CBD.
There are CBD products available on the market for medical, therapeutic, or dietary uses without regulatory approval and without regulatory authority review. However, these products have have no proof of being safe or effective because nobody evaluated them for
The FDA supports the development of new drugs, but these potential medications must undergo a rigorous drug approval process. First, the maker of the drug conducts a large number of scientific investigations and experiments to support their claims.
For example, in the US, companies need to submit an Investigational New Drug Application to the FDA’s Center for Drug Evaluation and Research. However, conducting clinical research using cannabis-related products that are CSA scheduled often involves other federal agencies besides the FDA, such as:
Before entering the market, drugs must receive approval from the FDA through a process called New Drug Application (NDS). Alternatively, they can undergo an over-the-counter (OTC) drug review. According to the FDA, however, CBD is not an OTC drug either.
There are six phases of clinical research that are necessary in order to collect evidence that a new drug works:
The drug maker will provide scientific publications of these experiments in order to receive regulatory approval. The regulatory agency will then decide based on this submitted information whether to approve the drug.
Despite the strict FDA regulation, there are other ways to legally try cannabis-based medications in the US. Patients can have access to cannabis-derived products that are not yet FDA approved medications through: