FDA approves additional information in labeling for Kybella

The US Food and Drug Administration (FDA) has approved an additional warning in labeling for Kybella (deoxycholic acid) injection regarding adverse reactions associated with use of the drug outside of the submental fat region (fat under the chin, known as a “double chin”) and recommends against this unapproved use.

In 2015, the FDA approved Kythera Biopharmaceuticals’ (Nasdaq: KYTH) Kybella, a treatment for adults with moderate-to-severe fat below the chin, known as submental fat. Using Kybella for the treatment of fat outside of the submental area is not approved and is not recommended.