FDA Accepts Merz’s PMA Application For Belotero Balance

The FDA has accepted for review Merz Pharmaceuticals’ (Merz) premarket approval (PMA) application for Belotero Balance.

Belotero Balance is a hyaluronic acid-based monophasic gel dermal filler that utilizes a cohesive polydensified matrix (CPM) technology. The application seeks FDA approval for injection into mid to deep dermis for correction of moderate to severe wrinkles and folds.

The company said that Belotero is also approved for aesthetic use in the UK, Italy, Russia, Austria and Switzerland.

Jack Britts, president and CEO of Merz, said: “The FDA’s acceptance for review of the Belotero Balance PMA begins the application review process and signifies the beginning of Merz Pharmaceutical’s firm footprint in the American aesthetics market.”