Document ID: FDA-2023-N-0148-0001
Agency: fda
Document Type: Notice
Title: Emergent Biosolutions Inc.; Withdrawal of Approval of a Supplemental New Drug Application for NARCAN (Naloxone Hydrochloride) Nasal Spray, 2 Milligrams/0.1 Milliliter
Posted Date: 2023-02-10T05:00Z

[Federal Register Volume 88, Number 28 (Friday, February 10, 2023)]
[Notices]
[Page 8873]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-02823]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-N-0148]

Emergent Biosolutions Inc.; Withdrawal of Approval of a 
Supplemental New Drug Application for NARCAN (Naloxone Hydrochloride) 
Nasal Spray, 2 Milligrams/0.1 Milliliter

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is 
withdrawing the approval of a supplemental new drug application (sNDA) 
for NARCAN (naloxone hydrochloride) nasal spray, 2 milligrams (mg)/0.1 
milliliter (mL), held by Emergent Biosolutions Inc., 400 Professional 
Dr., Suite 400, Gaithersburg, MD 20879. Emergent Biosolutions, Inc., 
has notified the Agency in writing that NARCAN (naloxone hydrochloride) 
nasal spray, 2 mg/0.1 mL, is not marketed and has requested that 
approval of the sNDA be withdrawn. This action has no impact on the 
continued approval and marketing of NARCAN (naloxone hydrochloride) 
nasal spray, 4 mg/0.1 mL.

DATES: Applicable February 10, 2023.

FOR FURTHER INFORMATION CONTACT: Ayako Sato, Center for Drug Evaluation 
and Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 51, Rm. 6206, Silver Spring, MD 20993-0002, 240-402-4191.

SUPPLEMENTARY INFORMATION: Emergent Biosolutions, Inc., has informed 
FDA that NARCAN (naloxone hydrochloride) nasal spray, 2 mg/0.1 mL, is 
not marketed and has requested that FDA withdraw approval of sNDA-001 
208411, approved on January 24, 2017, under the process in Sec.  
314.150(c) (21 CFR 314.150(c)). Emergent Biosolutions, Inc., has also, 
by its request, waived its opportunity for a hearing. Withdrawal of 
approval of an application under Sec.  314.150(c) is without prejudice 
to refiling.
    Therefore, approval of the sNDA for NARCAN (naloxone hydrochloride) 
nasal spray, 2 mg/0.1 mL, is hereby withdrawn as of February 10, 2023. 
Introduction or delivery for introduction into interstate commerce of 
such product without an approved new drug application violates section 
505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355(a) and 331(d)). Any NARCAN (naloxone hydrochloride) nasal 
spray, 2 mg/0.1 mL that is in inventory on February 10, 2023 may 
continue to be dispensed until the inventory has been depleted or the 
drug product has reached its expiration date or otherwise becomes 
violative, whichever occurs first.

    Dated: February 6, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-02823 Filed 2-9-23; 8:45 am]
BILLING CODE 4164-01-P