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 The leading web portal for pharmacy resources, news, education and careers October 20, 2017
Pharmacy Choice - Pharmaceutical News - Allergan Says FDA Approves JUV?DERM VOLLURE XC - October 20, 2017

Pharmacy News Article

 3/20/17 - Allergan Says FDA Approves JUV?DERM VOLLURE XC

WASHINGTON (dpa-AFX) - Allergan plc. (AGN) said that it has received approval from the U.S. Food and Drug Administration to market JUV?DERM VOLLURE XC, for correction of moderate to severe facial wrinkles and folds, such as nasolabial folds, in adults over the age of 21. JUV?DERM 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.

JUV?DERM VOLLURE XC was first approved in Europe as JUV?DERM VOLIFT in 2013. The JUV?DERM family of products is marketed and sold in more than 80 countries outside the United States.



Copyright RTT News/dpa-AFX

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