Notice2024-18269
Cubist Pharmaceuticals LLC; Withdrawal of Approval of a New Drug Application for ENTEREG (Alvimopan) Capsules, 12 Milligrams
Primary source
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Published
August 15, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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Agency in writing that the drug product was no longer marketed and requested that the approval of the application be withdrawn.
Full Text
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<title>Federal Register, Volume 89 Issue 158 (Thursday, August 15, 2024)</title>
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[Federal Register Volume 89, Number 158 (Thursday, August 15, 2024)]
[Notices]
[Page 66413]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-18269]
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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.
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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withdrawn.
DATES: Approval is withdrawn as of September 16, 2024.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, <a href="/cdn-cgi/l/email-protection#89c2e0e4ebecfbe5f0a7c5ece1fbefece5edc9efede8a7e1e1faa7eee6ff"><span class="__cf_email__" data-cfemail="054e6c68676077697c2b49606d7763606961456361642b6d6d762b626a73">[email protected]</span></a>.
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
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