India, Sept. 11 -- Hikma Pharmaceuticals PLC (HKMPY,HIK.L), a drug manufacturer, on Thursday announced that regulators in the United States, Europe, and the UK have accepted for review its regulatory submissions for an epinephrine nasal spray developed to treat allergic reactions (anaphylaxis) in an emergency.
Hikma's epinephrine nasal spray is an investigational, non-injectable product designed for the emergency treatment of allergic reactions (anaphylaxis).
The submission to the US Food and Drug Administration (FDA) includes a non-clinical and clinical data package for regulatory review.
Hikma's hybrid marketing authorisation dossier for the nasal spray has been accepted for review in Europe and the UK via the Decentralised and Nationa...