[Federal Register Volume 90, Number 49 (Friday, March 14, 2025)]
[Notices]
[Pages 12162-12163]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-04101]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2024-N-5852]


Sage Therapeutics, Inc.; Withdrawal of Approval of a New Drug 
Application for ZULRESSO (Brexanolone) Solution, 100 Milligrams/20 
Milliliters

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is 
withdrawing approval of a new drug application (NDA) for ZULRESSO 
(brexanolone) solution, 100 milligrams (mg)/20 milliliters (mL), held 
by Sage Therapeutics, Inc., 55 Cambridge Parkway, Cambridge, MA 02142 
(Sage). Sage notified the Agency in writing that the drug product was 
no longer marketed and requested that the approval of the application 
be withdrawn.

DATES: Approval is withdrawn as of April 14, 2025.

FOR FURTHER INFORMATION CONTACT: Kimberly Lehrfeld, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6226, Silver Spring, MD 20993-0002, 301-
796-3137, [email protected].

SUPPLEMENTARY INFORMATION: Sage has informed FDA that ZULRESSO 
(brexanolone) solution, 100 mg/20 mL, is no longer marketed and has 
requested that FDA withdraw approval of NDA 211371 under the process in 
Sec.  314.150(c) (21 CFR 314.150(c)). Sage has also, by its request, 
waived its opportunity for a hearing. Withdrawal of approval of an 
application or abbreviated application under Sec.  314.150(c) is 
without prejudice to refiling.
    Therefore, approval of NDA 211371, and all amendments and 
supplements thereto, is hereby withdrawn as of April 14, 2025. Approval 
of the entire application is withdrawn, including any strengths and 
dosage forms included in the application but inadvertently

[[Page 12163]]

missing from this notice. Introduction or delivery for introduction 
into interstate commerce of ZULRESSO (brexanolone) solution, 100 mg/20 
mL, without an approved NDA violates sections 505(a) and 301(d) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(a) and 331(d)). Any 
ZULRESSO (brexanolone) solution, 100 mg/20 mL, that is in inventory on 
April 14, 2025 may continue to be dispensed until the inventories have 
been depleted or the drug products have reached their expiration dates 
or otherwise become violative, whichever occurs first.

    Dated: March 7, 2025.
P. Ritu Nalubola,
Associate Commissioner for Policy.
[FR Doc. 2025-04101 Filed 3-13-25; 8:45 am]
BILLING CODE 4164-01-P