Posted by Michael Wonder on 21 Feb 2017
Amphastar announces the receipt of a complete response letter for intranasal naloxone for the emergency treatment of opioid overdose
21 February 2017 - Amphastar Pharmaceuticals announced today that the U.S. FDA issued a complete response letter for its new drug application for naloxone hydrochloride 2 mg/0.5 mL nasal spray, indicated for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression.
The letter identifies issues including user human factors study, device evaluation, and other items that need to be addressed before the application can be approved.
