On October 1st, Allergan (BOTOX, Juvéderm, Voluma, Latisse and now Kybella) announced the FDA approval to market Juvéderm Ultra XC for injection into the lips and around the mouth for lip augmentation.
But wait, you say, I have had Juvéderm Ultra XC for my lips many times. Indeed. Juvéderm Ultra XC has been available for injection in the U.S. since 2006. The original approval was to allow marketing Juvéderm Ultra XC for severe wrinkles and folds such as parentheses lines around the nose and mouth.
The difference is subtle but here is how it works. Once the FDA approves a drug, or in this case hyaluronic dermal filler, the manufacturer can begin marketing the drug for a specific treatment (illness, disease, etc.). A licensed physician, however, can prescribe a drug for a different condition than those specifically approved by the FDA for marketing. This type of prescription is called “off-label” because treatment for only those specific conditions approved for marketing by the FDA appear on the label. Examples of common off-label medication use include high-dose amoxicillin for otitis media (ear infection) in children, beta-blockers (heart medication) for social phobias and public speaking, and tricyclic antidepressants for neuropathic pain syndromes (medical school is four years of learning a foreign language).
Juvéderm Ultra XC has been used off-label for lip augmentation since its initial approval in 2006. By now having FDA approval and hence labeling, Allergan can market it for lip augmentation.
Come in and see if Juvéderm Ultra XC is right for you and your lips; tonight give someone special a big(ger) kiss!
Thank you for your time and attention,
Robert Zieber, MD
De Luz Medical Aesthetics