FDA accepts AstraZeneca's new drug application

19th Nov 2013 07:37

AstraZeneca said the US Food and Drug Administration (FDA) has accepted its new drug application (NDA) for naloxegol, which is used for the treatment of opioid-induced constipation (OIC).The company filed the NDA after completing the Phase III KODIAC programme, which included four clinical trials designed to investigate the safety and efficacy of naloxegol.Naloxegol is part a license agreement announced in September 2009, between AstraZeneca and Nektar Therapeutics. Under the deal, AstraZeneca will make a $70m payment to Nektar within five business days of acceptance of the NDA by the FDA.RD