Japan Approves Prolacta Bioscience's PreemieFort as Prescription Drug

Japan's Japan===Ministry of Health, Labour and Welfare (MHLW) has approved Prolacta Bioscience's PreemieFort Enteral Solution, a 100% human milk-based fortifier, as a prescription drug. This approval is for very low birth weight infants, infants with congenital gastrointestinal disorders or congenital heart diseases, and those recovering from gastrointestinal surgery. This regulatory milestone was achieved in partnership with the Clinigen Group, which will serve as the Marketing Authorization Holder and distributor in Japan. The decision, informed by the JASMINE clinical trial, validates the critical role of Prolacta Bioscience's human milk-based fortifiers and sets a powerful precedent for neonatal intensive care units (NICUs) worldwide. This makes Japan the first nation to grant prescription drug status to such a product, highlighting its stringent regulatory and quality requirements.