FDA Confirms Paragraph IV Patent Litigation for Trifarotene
Galderma’s acne cream AKLIEF (trifarotene 50 mcg) has received approval by the European Union after reviewing its summary of product characteristics, package leaflet and labelling.
Galderma, a global leader focused on meeting the world's increasing skin health needs, announced today that the U.S. Food and Drug Administration (FDA) approved AKLIEF® (trifarotene) Cream, 0.005% for the topical treatment of acne. AKLIEF Cream is the only topical retinoid that selectively targets retinoic acid receptor (RAR) gamma, the most common RAR found in the skin.1,2,3 Trifarotene is the first new retinoid molecule to receive U.S. FDA approval for the treatment of acne in more than 20 years.4,5,6 AKLIEF Cream is the first topical treatment specifically studied and proven to treat both facial (forehead, cheeks, nose and chin) and truncal (chest, shoulders and back) acne, offering healthcare professionals and acne patients another treatment option