FDA OKs Rx for ‘Smile Lines’

March 30, 2017 / Allergan, Brilliant Distinctions, dermal filler, Hyaluronic Acid, Injectables, Juvederm

Juvederm Vollure XC approved by FDA to combat nasolabial folds

March 22, 2017

(RxWiki News) The US Food and Drug Administration has approved Allergan’s Juvederm Vollure XC for use in combating moderate to severe facial wrinkles and folds.

The injection was approved for use in adults older than 21, according to a press release from Allergan.

Juvederm Vollure

Juvederm Vollure XC’s approval came after a clinical trial found that nearly 60 percent of participants saw an improvement in nasolabial folds — known commonly as “laugh lines” or “smile lines” — for as long as 18 months. That study also found that more than 82 percent of patients after six months and 68 percent after 18 months were satisfied with the treatment.

The most common side effects were injection-site reactions, such as itching, discoloration, pain, redness, lumps or bumps, firmness, bruising, tenderness and swelling.

A risk tied to Juvederm Vollure XC is unintentional injection into a blood vessel. Although Allergan noted that this risk was relatively small, the complications of it can be serious and permanent. Complications include permanent scarring, stroke, blindness, vision abnormalities and temporary scabs.

Juvederm Vollure

Also, all skin injection procedures come with a risk of infection.

According to Allergan, Juvederm Vollure XC will be available in the US in April of this year by prescription only. The product was approved in Europe in 2013.

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Reposted from: RXWiki