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FDA Panel Backs Approval of Restylane for Lip Augmentation

By admin March 5, 2013

Friday, June 24, 2011

Dermatologists may not have to use Restylane off label for lip augmentation any longer. On April 27, a Food and Drug Administration panel voted 6-0 with 1 abstention that benefits outweigh risks for using the filler as a submucosal injection for lip augmentation.

The panel also voted 6-0 with 1 abstention that the filler is safe and effective for the expanded indication.

Restylane (Medicis Aesthetics) is a hyaluronic acid gel generated byStreptococcus bacteria, chemically crosslinked with 1,4 butanediol diglycidyl ether. The filler was first approved in 2005 for mid-to-deep dermal implantation for the correction of moderate-to-severe facial wrinkles and folds, such as nasolabial folds.

https://www.facialesthetics.org/blog/fda_panel_backs_approval_of_restylane_for_lip_augmentation

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