US: FDA to speed review of generic versions of opioid overdose antidote

08-07-2019

US: FDA to speed review of generic versions of opioid overdose antidote

(Source: RAPS 2019-07-09)

The US Food and Drug Administration (FDA) on Monday said it would prioritize and expedite the review of generic versions of drugs indicated for the emergency treatment of opioid overdoses.

The decision follows FDA’s approval in Aprilof 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.

As part of this priority review, already-submitted ANDAs may receive either shorter goal dates or an expedited review, in addition to the possibility of increased communications with the agency, FDA says.

To continue reading this article please go to RAPS

New Article