Piramal Pharma Limited, in collaboration with BrePco Biopharma Ltd, has received regulatory approval from the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) for Naeoatricon, a new pediatric-strength dopamine hydrochloride infusion for the treatment of hypotension in neonates, infants, and children. Piramal Critical Care (PCC) has secured commercialization rights for the EU, UK, and Norway, and will manage the product in these regions.
Naeoatricon is an age-appropriate, ready-to-use, sterile solution for infusion of dopamine hydrochloride, available in two concentrations: 1.5mg/mL in a 30 mL vial and 4.5mg/mL in a 50 mL vial. Until now, there has been no approved dopamine hydrochloride formulation specifically indicated for use in neonates, infants, or children, with off-label use being a common practice.
The approval of Naeoatricon aims to address this gap, ensuring accurate dosing, minimizing the risk of under or overdosing, and reducing preparation time in neonatal and pediatric intensive care units (NICU & PICU), thus enabling faster intervention in emergency settings. With this approval, Naeoatricon sets a new standard in pediatric critical care.
The availability of Naeoatricon is a significant development in the field of pediatrics, as it provides a safe and reliable solution for healthcare professionals and parents. It aims to improve patient outcomes and optimize treatment in neonatal and pediatric critical care units, ultimately leading to better health outcomes for the most vulnerable patients.