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Is Voluma (By Juvederm) FDA Approved Yet? If Not, Why Not? What Could Be the Concerns?

asked 7 months ago by Emmanouella in Madrid
Latest answer by Eugene Mandrea, MD
Question viewed 400 times
Tags: FDA, risk, Voluma

Is Voluma (By Juvederm) FDA Approved Yet? If Not, Why Not? What Could Be the Concerns? 

5 answers to Is Voluma (By Juvederm) FDA Approved Yet? If Not, Why Not? What Could Be the Concerns?

+1

Juvederm V oluma not approved yet

Juvederm Voluma has some advantages over Restylane in that the Voluma particles are more uniform, more oval shaped (easier to inject without nodule formation) and more cross-linked (longer duration). The Food and Drug Administration is perhaps more thorough than regulatory agencied in other countries and the fact that Voluma is approved in other countries and not yet in the USA, reflects this fact. Voluma should be approved within the next few months. Make... more
Eugene Mandrea, MD

Chicago Dermatologist
+1

Juvederm Voluma is still in extensive clinical trials for the FDA.

The study is a large, 2 year study to evaluate results and safety. I have heard many positive things about both the results adn the safety data. The FDA does its best to make sure fillers are safe before they come into the market place. I would anticipate next year, but there is never any firm timetable from the FDA. It is supposed to be a game chager for cheek volume restoration.
Mary Lupo, MD

New Orleans Dermatologist
+1

Voluma and FDA

I have no specific information about this drug but will tel lyou that the FDA in the US is not a department that will approve anything too quickly as they will be very careful in evaluating everything about the drug, the testing and how will be used by whom. The chances are that this is a time issue and not a quality issue when it comes to drug itself.
Jo Herzog, MD

Birmingham Dermatologist
+1

Juvéderm Voluma® has proved to be an excellent product in Canada

Juvéderm Voluma® has proved to be an excellent product in Canada and Europe, and is close to FDA approval in the US. Sometimes the US is a little bit ahead of the rest of the world approving drugs and devices, sometimes the regulatory process in the US runs a little slower. I expect Voluma® to reach the US market in the near future.
Kevin C. Smith, MD

Niagara Falls Dermatologic Surgeon
+1

Voluma is in FDA trials

Voluma by Allergan is currently in FDA trials. I was told recently by a rep that they were expecting it to be early 2012, but now it's looking more like 2013 for approval. There are not necessarily concerns, but all aspects of the injectable need to be properly studied. It takes years for drugs/medications/injectables to get through trails - not necessarily because of concerns, but so that all aspects are covered, studied, and reviewed properly.
F. Victor Rueckl, MD

Las Vegas Dermatologist

www.lakesdermatology.com

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