2024-18269. Cubist Pharmaceuticals LLC; Withdrawal of Approval of a New Drug Application for ENTEREG (Alvimopan) Capsules, 12 Milligrams

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Department of Health and Human Services

Food and Drug Administration

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

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Agency in writing that the drug product was no longer marketed and requested that the approval of the application be withdrawn.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Approval is withdrawn as of September 16, 2024.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, [e-mail].

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 § 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 § 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Therefore, approval of NDA 021775, and all amendments and supplements thereto, is hereby withdrawn as of September 16, 2024. Approval of the entire application is withdrawn, including any strengths and dosage forms included in the application but inadvertently missing from this notice.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.