Piramal Critical Care, a part of Piramal Pharma Ltd., and Ireland-based BrePco Biopharma have received marketing approval from the UK Medicines and Healthcare products Regulatory Agency for a medication used in the treatment of low blood pressure and low heart rate in children.
Piramal Critical Care has secured the commercialisation rights for Neoatricon, the first paediatric strength solution for infusion of Dopamine Hydrochloride, for the EU, the UK, and Norway markets, Piramal Pharma said in a regulatory filing.
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PCC would be responsible for distributing Neoatricon in these regions, it added.
Developed by BrePco Biopharma, Neoatricon is an age-appropriate, ready-to-use, sterile solution for infusion of Dopamine Hydrochloride.
It is available in a concentration of 1.5mg/mL in a 30 mL vial and a higher strength containing 4.5mg/mL in a 50 mL vial.
Currently, there are no approved Dopamine Hydrochloride formulations specifically indicated for use in neonates, infants, or children, with off-label use remaining a common practice.
The approval of Neoatricon addresses this critical gap by ensuring precise dosing, reducing the risk of under-or overdosing, and minimising preparation time in neonatal and paediatric intensive care units facilitating faster intervention in emergency settings, the company said.
"This milestone marks an important step for Piramal Critical Care as we expand into a new therapeutic area. Our partnership with BrePco Biopharma has allowed us to bring forward an innovation that will significantly improve health outcomes for paediatric patients," Piramal Global Pharma Chief Executive Officer Peter DeYoung said.
Shares of Piramal Pharma on Thursday ended 1.26% up at Rs 221.25 apiece on BSE.
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