Horizon's NDA for Procysbi New Dosage Form Accepted by FDA

Horizon Therapeutics plc (HZNP announced that the FDA has accepted its new drug application (NDA) for Procysbi (Cysteamine Bitartrate) delayed-release oral granules in packets. Procysbi is a delayed-release capsule form of cysteamine bitartrate that works by continuously reducing the toxic concentration of cystine in the cells. It plays an important role in managing nephropathic cystinosis and is already approved for adults and minors as young as one-year olds.