Allergan plc. (AGN) said that it has received approval from the U.S. Food and Drug Administration to market JUVÉDERM VOLLURE XC, for correction of moderate to severe facial wrinkles and folds, such as nasolabial folds, in adults over the age of 21. JUVÉDERM VOLLURE XC will be available to physicians in April 2017.
In the US pivotal clinical trial, a majority (59%) of subjects saw improvement in moderate to severe nasolabial folds for up to 18 months. Patient satisfaction in the pivotal study was also high: 82% of patients said they were very satisfied at 6 months and 68% at 18 months.
The most common side effects seen in the clinical study were temporary injection site responses at the treatment site such as swelling, tenderness, bruising, firmness lumps/bumps, redness, pain, discoloration, and itching. Most of these side effects resolved within 1 week.
JUVÉDERM VOLLURE XC was first approved in Europe as JUVÉDERM VOLIFT in 2013. The JUVÉDERM family of products is marketed and sold in more than 80 countries outside the United States.
by RTT Staff Writer
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