What term describes medications not approved by the FDA for a specific condition?

The term that describes medications not approved by the FDA for a specific condition is off-label medications. Off-label use refers to the practice of prescribing a medication for a condition or in a manner that is not included in the official labeling approved by the FDA.

This can occur for a variety of reasons; healthcare providers may determine that a medication could be effective for a certain condition based on clinical evidence, even if that specific use hasn’t been formally approved by the FDA. This practice is legal and common in clinical settings, as physicians have the autonomy to use their professional judgment in treating patients, which can include prescribing off-label medications when appropriate.

In this context, prescription-only medications refer to those that require a doctor's order for use, generic medications are those that are chemically identical to brand-name drugs but sold at lower prices, and over-the-counter drugs are available without a prescription and typically treat common ailments. While all these options relate to medications, none specifically defines the scenario of a medication being used for an unapproved indication as effectively as off-label medications do.