Heart Inflammation Warning Added to EUA Fact Sheets for Pfizer/BioNTech and Moderna COVID-19 Vaccines
June 25, 2021Teva Recalls Topotecan Injection to Retail/Institutional Level
June 30, 2021Restylane Contour Approved for Cheek Augmentation and Correction of Midface Contour Deficiencies in Adults
June 29, 2021 – The U.S. FDA has approved Restylane® Contour, a hyaluronic acid filler manufactured by Galderma, to provide cheek augmentation and correction of midface contour deficiencies in adults over the age of 21.
In a clinical trial, Restylane Contour was found to be safe and effective for cheek augmentation and the correction of midface contour deficiencies. It also required less total volume (4.26mL) to achieve results versus a comparator (4.88mL). Of the patients who received Restylane Contour, 76% were satisfied with the results at week 48, while less than 73% of patients who received the comparator reported the same. In a second Restylane Contour study group, more than 91% of recipients were satisfied with the results.
Restylane Contour is Galderma’s first U.S. product made using XpresHAn TechnologyTM that, according to Galderma, "creates a smooth, injectable gel that integrates into the skin for natural, dynamic expression in motion."
The product is the latest in a series of Restylane hyaluronic acid fillers manufactured by Galderma and approved for use in the United States. Other products include Restylane-L, Restylane Refyne, Restylane Defyne, Restylane Lyft with lidocaine, Restylane Silk, and Restylane Kiss. Restylane products are used as indicated to smooth facial wrinkles and folds, augment and correct mild to moderate chin retrusion, create fuller and more accentuated lips, augment cheeks and correct midface contour deficiencies, and/or add lift and volume to the cheeks and back of the hands. All Restylane products must be administered by a qualified healthcare professional according to FDA and manufacturer guidelines.
Galderma plans to launch Restylane Contour during the summer of 2021.