"FDA approved" vs "MHRA licensed"
The US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA) are SEPARATE regulators. An "FDA approved" status has no formal UK regulatory meaning. UK clinicians prescribe and supply medicines based on MHRA marketing authorisations, not FDA approvals.
Full definition
US-headquartered brands frequently describe products as "FDA approved" in marketing aimed at UK consumers. The FDA does not regulate UK supply. The relevant UK authority is the MHRA, which grants UK marketing authorisations recorded in the eMC (medicines.org.uk). A product can be FDA approved but unlicensed in the UK (and vice versa). For UK patients, what matters is the MHRA marketing authorisation and the Summary of Product Characteristics (SmPC) that comes with it.
What it does not mean
FDA approval does NOT mean MHRA-licensed in the UK. It does NOT mean a product is legal to supply against UK prescriptions without additional regulatory consideration (although doctors may prescribe imported FDA-approved products as unlicensed specials in some circumstances). It does NOT mean the product carries the same patient information leaflet (PIL) as the UK-licensed equivalent.
Examples in use
Honest use
"Finasteride 1 mg is licensed in the UK under MHRA marketing authorisation PL [number], with the SmPC available on the eMC."
Common misuse
"FDA approved for hair loss." (When marketing to UK patients, this conflates regulators.)