[Federal Register Volume 89, Number 158 (Thursday, August 15, 2024)]
[Notices]
[Page 66413]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-18269]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2024-N-3028]


Cubist Pharmaceuticals LLC; Withdrawal of Approval of a New Drug 
Application for ENTEREG (Alvimopan) Capsules, 12 Milligrams

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or Agency) is 
withdrawing approval of a new drug application (NDA) for ENTEREG 
(alvimopan) Capsules, 12 milligrams (mg), held by Cubist 
Pharmaceuticals LLC, 126 East Lincoln Ave., Rahway, NJ 07065 (Cubist). 
Cubist 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withdrawn.

DATES: Approval is withdrawn as of September 16, 2024.

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: Cubist has informed FDA that ENTEREG 
(alvimopan) Capsules, 12 mg is no longer marketed and has requested 
that FDA withdraw approval of NDA 021775 under the process in Sec.  
314.150(c) (21 CFR 314.150(c)). Cubist 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 021775, and all amendments and 
supplements thereto, is hereby withdrawn as of September 16, 2024. 
Approval of the entire application is withdrawn, including any 
strengths and dosage forms included in the application but 
inadvertently missing from this notice. Introduction or delivery for 
introduction into interstate commerce of ENTEREG (alvimopan) Capsules, 
12 mg 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 ENTEREG (alvimopan) Capsules, 12 mg, that is in inventory on 
September 16, 2024 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: August 12, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-18269 Filed 8-14-24; 8:45 am]
BILLING CODE 4164-01-P