What does FDA approval tell me?

Approved: checked for a particular use

FDA (the U.S. drug agency) approval concerns a specific medicine and the uses on its label.

In the United States, approved products include semaglutide under the names Ozempic and Wegovy, and tirzepatide under Mounjaro and Zepbound.

Approved uses include diabetes care and weight loss, with the exact uses differing by product.

The brand and form matter; semaglutide has approved tablets as well as injections.

Label: the information for that product

Ask for the exact name and form, then ask which use on the label matches the proposed care.

A familiar drug name is a starting point for a conversation. It cannot answer whether the treatment fits your own situation.

Generic: an approved version

An approved medicine that copies a brand medicine is called a generic.

At the September check, there was no approved generic semaglutide or tirzepatide available.

A compounded medicine is made or changed by a pharmacy to meet a patient’s need. That finished medicine has no FDA approval, unlike an approved generic.

Code: identification does not mean approval

The number identifying a drug-list entry is called a National Drug Code, or NDC.

FDA says an NDC listing does not establish that it approved the product.

If a code is offered as proof, ask for the actual approved product and its label.