FDA Advisory Committee Recommends Juvederm Voluma XC for Cheek Augmentations
Posted on May 4, 2013 | by Boston Plastic SurgeryEarlier this week Allergan, Inc. announced that the U.S. Food and Drug Administration’s (FDA) General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee recommended Juvéderm Voluma XC as a safe treatment option for cheek augmentations.
The unanimous vote to recommend it by the Medical Devices Advisory Committee, while not binding, will be taken into account when the FDA makes it’s final approval decision.
Juvéderm Voluma XC is an injectable hyaluronic acid dermal filler that would be used to correct volume deficiencies in the mid-face. This distinction would be the first and only of its kind for dermal fillers in the U.S. market, if the FDA approves it.
In a company press release Allergan’s Scott M. Whitcup M.D., the Executive Vice President, Research and Development, and Chief Scientific Officer stated: “ Today’s recommendation is an important step in the FDA review process for Juvéderm Voluma XC.”
Whitcup went on to say that Allergan is committed to working with the FDA to provide consumers with “the first treatment option that has been specifically developed” to treat age-related volume deficiencies in the cheek.
If approved by the FDA, Allergan expects to launch Voluma XC later this year.
More About Allergan, the Company Behind Juvéderm Voluma XC
Established in 1950, in Los Angeles, CA, Allergan, Inc. started as an eye care company with the first antihistamine eye drop in the United States.
Sixty years later and now a multi-specialty health care company, Allergan focuses on a number of medical specialties including: eye care, medical aesthetics, breast aesthetics, urologics, obesity intervention, neurosciences, and dermatology.
In addition to Juvéderm, Allergan also manufactures the injectable treatment Botox and topical treatment Latisse. Their portfolio of products also includes the Natrelle line of breast implants.