The first OTC acne treatment proposed in a new drug application, Differin Gel 0.1%, will compete in a market that has included only monograph-ingredient products, led by the Neutrogena and Clearasil brands.
Galderma Pioneers NDA Path Into OTC Acne Treatment Market
FDA on July 8 announces approval for Galderma Laboratories to market Differin Gel 0.1% (adapalene) as an OTC, once-daily topical for treatment of acne by consumers 12 years old and up.
More from Review Pathways
More from Pathways & Standards
• By
CEO Len Schleifer said during the company’s first quarter earnings call that most of the complete response letters the company has received related to third-party suppliers, not efficacy or safety.
• By
Plozasiran, Arrowhead Pharmaceuticals' treatment for familial chylomicronemia syndrome, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.
• By
FDA Commissioner Martin Makary said in an interview that he will use the current structure to reform the agency. He also plans to address employee morale.