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# Restrictions Sought on Generic Naloxone Products
- URL: https://www.fdaweb.com/restrictions-sought-on-generic-naloxone-products/
- Published: 2016-11-30T12:00:00.000Z
- Updated: 2026-09-14T21:51:32.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5137461

Adapt Pharma Operations has filed a citizen [petition](https://www.regulations.gov/contentStreamer?documentId=FDA-2016-P-4094-0001&attachmentNumber=1&disposition=attachment&contentType=pdf&ref=fdaweb.com) asking that FDA require sponsors of ANDAs for generic intranasal naloxone products to submit specific types of data to support the interchangeability of the generic version of its reference-listed product (Narcan). Specifically, the petition asks that FDA: 

- not approve a generic application for an intranasal naloxone product intended for community use before establishing a guidance for a product-specific bioequivalence recommendation that addresses standards to ensure its safe and effective use in emergency treatment for opioid overdose and comparability of the device with the reference-listed device;
- ensure that the stability of the generic product should be established in three storage positions — horizontal, upright, and inverted at cold temperature and accelerated storage conditions for 24 months or over the shelf life period, together with specific chemistry, manufacturing, and controls requirements; and
- not approve a specific ANDA for naloxone hydrochloride nasal spray 4mg/spray until all the requested actions have been evaluated and implemented by FDA and met by the ANDA sponsor.

The petition says that the requested pharmacokinetic requirements are consistent with briefing materials FDA presented to a 10/5 joint meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee. Also, it says, certain of the requirements are consistent with requirements for agency approval of Narcan.