Valeant announced that the FDA has issued clearance for Restylane Silk Injectable Gel with 0.3% Lidocaine, a submucosal implant for lip augmentation and dermal implantation for correction of perioral rhytids in patients >21 years old.

Restylane Silk is a crystal injectable gel that consist of hyaluronic acid. It is non-animal based and free form animal protein. The 0.3% lidocaine reduces the discomfort associated with the treatment.

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The safety and efficacy of Restylane Silk was evaluated in 221 mostly female patients. The results showed 98% of patients reported an improvement in lip fullness 14 days after injection and 76% still had lip improvement 6 months post-injection.

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