Posted by Michael Wonder on 09 Jul 2019
FDA to speed review of generic versions of opioid overdose antidote
8 July 2019 - The US FDA on Monday said it would prioritise and expedite the review of generic versions of drugs indicated for the emergency treatment of opioid overdoses.
The decision follows FDA’s approval in April of the first generic of the life-saving naloxone nasal spray, commonly known as Narcan.
Under the “Public Health Emergency” prioritization factor in MAPP 5240.3, FDA says it will expedite the review of all abbreviated new drug applications (ANDAs) that reference new drug applications (NDAs) for drugs indicated for the emergency treatment of known or suspected opioid overdose. The NDAs include the Narcan injection and nasal spray, Evzio auto-injector and Revex injection.
