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# Narcan Petition Approved in Part
- URL: https://www.fdaweb.com/narcan-petition-approved-in-part/
- Published: 2017-04-26T12:00:00.000Z
- Updated: 2026-09-14T22:20:10.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5138546

FDA has granted in part and denied in part an Adapt Pharma Operations 11/23/16 petition asking that the agency not approve any ANDA referencing Adapt’s Narcan (naloxone hydrochloride) nasal spray that does not provide specific pharmacokinetic, device, stability, and chemistry, manufacturing, and controls data.

FDA’s response [letter](https://www.regulations.gov/contentStreamer?documentId=FDA-2016-P-4094-0003&attachmentNumber=1&contentType=pdf&ref=fdaweb.com) says the agency agreed that a product-specific guidance for naloxone nasal spray would be helpful to applicants developing generic intranasal naloxone products and issued such a guidance concurrent with the petition response. The draft guidance recommends two different approaches for demonstrating bioequivalence, the letter says, and includes information on the device component of a proposed generic. Thus, the company’s request for a product-specific guidance is granted.

Another element of the Adapt request was granted to the extent that the draft guidance includes recommendations about pharmacokinetic testing at early time points. But the request to include specific partial AUC time points was denied.

FDA did not accept an Adapt request that human factor studies be required. And a request that generic manufacturers be required to include a minimum of two doses per pack was also denied.