Piramal Pharma secures Approval to Launch Neoatricon in the UK

The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has approved Naeoatricon for use by Piramal Critical Care (PCC) and Ireland-based BrePco Biopharma Ltd (BPCO), according to a statement from Piramal Pharma Limited. It is the first pediatric-strength infusion of dopamine hydrochloride used to treat hypotension in newborns, babies, and kids.

Piramal Critical Care will handle Neoatricon in the EU, UK, and Norway, where it has reserved the right to commercialize the product. With the governmental approval, PCC has significantly expanded into pediatric critical care.

Neoatricon is a sterile, age-appropriate, and readily usable solution for dopamine hydrochloride infusion. BrePco Biopharma is responsible for the drug's development. The medication comes in a 30 mL vial with a concentration of 1.5 mg/mL and a 50 mL vial with a higher strength of 4.5 mg/mL.

Off-label use of dopamine hydrochloride is nevertheless frequent because there are currently no approved formulations that are expressly indicated for use in neonates, babies, or children. By guaranteeing precise dosage, reducing the possibility of underdosing or overdose, and shortening the preparation time in newborn and pediatric intensive care units (NICU & PICU), Neoatricon's approval fills this critical gap and speeds up emergency response. Neoatrican sets a new benchmark in pediatric critical care with this approval.