Unapproved use of an approved drug is often called “off-label” use. This term can mean that the drug is:
- Used for a disease or medical condition that it is not approved to treat, such as when a chemotherapy is approved to treat one type of cancer, but healthcare providers use it to treat a different type of cancer.
- Given in a different way, such as when a drug is approved as a capsule, but it is given instead in an oral solution.
- Given in a different dose, such as when a drug is approved at a dose of one tablet every day, but a patient is told by their healthcare provider to take two tablets every day. (source: fda.com)