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# Draft Guide on Generic Narcan Bioequivalence Studies
- URL: https://www.fdaweb.com/draft-guide-on-generic-narcan-bioequivalence-studies/
- Published: 2017-04-21T12:00:00.000Z
- Updated: 2026-09-14T22:19:02.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5138505

FDA has released a [draft guidance](https://t.co/PhEL5Zx9Re?ref=fdaweb.com) on generic naloxone hydrochloride nasal spray entitled “Draft Guidance on Naloxone Hydrochloride.” The document provides product-specific recommendations on bioequivalence study designs to support ANDAs for naloxone hydrochloride (Narcan) nasal spray, indicated for treating opioid overdose.