FDA issues approvals for Radiesse®

Washington — The Food and Drug Administration has approved Radiesse®, a filler marketed by San Mateo, Calif.-based BioForm Medical Inc., for use in treating moderate to severe facial wrinkles and folds.

The product received a second FDA approval for use in correcting facial fat loss (lipoatrophy) in people with human immunodeficiency virus (HIV).

According to the company, Radiesse® is the first filler with calcium-based microsphere technology that stimulates production of new collagen as well as provides volume replacement. It is made of calcium hydroxylapatite microspheres in a water-based gel carrier.