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# FDA Withdrawals Emergent Narcan sNDA
- URL: https://www.fdaweb.com/fda-withdrawals-emergent-narcan-snda/
- Published: 2023-02-10T12:00:00.000Z
- Updated: 2026-09-14T18:15:30.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5153756

*Federal Register* notice: FDA is withdrawing the approval of an Emergent Biosolutions supplemental NDA for Narcan (naloxone hydrochloride 2 mg/.1 ml) after the company requested it because it is no longer marketed. FDA says the action has no impact on the continued approval and marketing of Narcan nasal spray, 4 mg/.1 mL, which is the subject of a 2/15 joint meeting of its Nonprescription Drugs Advisory Committee and Anesthetic and Analgesic Drug Products Advisory Committee ([see earlier notice](http://fdaweb.com/login.php?sa=v&aid=D5153499&cate=&stid=%241%24il5.Dw0.%24Ab3%2FnFxfZgAhfOlPGPccH.&ref=fdaweb.com)). Panel members there are scheduled to discuss a supplemental NDA that proposes the product’s use as a nonprescription treatment of known or suspected opioid overdose. To view the withdrawal notice, click [here](https://www.govinfo.gov/content/pkg/FR-2023-02-10/pdf/2023-02823.pdf?ref=fdaweb.com).