Allergan Says FDA OKs JUVÉDERM VOLUMA XC - Quick Facts

(RTTNews) - Allergan Inc. (AGN) has obtained approval from the U.S. Food and Drug Administration or FDA to market JUVÉDERM VOLUMA XC, the first and only filler approved to temporarily correct age-related volume loss in the cheek area in adults over the age of 21. JUVÉDERM VOLUMA XC helps create a more youthful appearance to the face and provides natural-looking and long-lasting results up to two years with optimal treatment.

The multi-specialty health care company conducted a pivotal study in the U.S. and Canada for submission to the FDA. The trial was designed to assess the safety and effectiveness of JUVÉDERM VOLUMA XC as a non-surgical option for patients desiring volume in the cheek area to correct age-related volume loss. The study showed that JUVÉDERM VOLUMA XC was an effective treatment compared to the control group, which did not receive treatment.

JUVÉDERM VOLUMA XC, which is made with Allergan's proprietary VYCROSS technology, would be available in fall 2013.