Cubist Pharmaceuticals LLC; Withdrawal of Approval of a New Drug Application for ENTEREG (Alvimopan) Capsules, 12 Milligrams, 66413 [2024-18269]
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Federal Register / Vol. 89, No. 158 / Thursday, August 15, 2024 / Notices
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[FR Doc. 2024–18309 Filed 8–14–24; 8:45 am]
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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.
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thereto, is hereby withdrawn as of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entire application is withdrawn,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
SUPPLEMENTARY INFORMATION:
Frm 00072
Fmt 4703
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
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, Kimberly.Lehrfeld@
fda.hhs.gov.
SUMMARY:
PO 00000
66413
Sfmt 4703
[Docket No. FDA–2024–N–1090]
Ryan Stabile: Final Debarment Order
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is issuing an
order under the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) debarring
Ryan Stabile for a period of 15 years
from importing or offering for import
any drug into the United States. FDA
bases this order on a finding that Mr.
Stabile was convicted of three felony
counts under Federal law: one count of
conspiracy and two counts of
introduction of misbranded drugs with
intent to defraud/mislead. The factual
basis supporting Mr. Stabile’s
conviction, as described below, is
conduct relating to the importation into
the United States of a drug or controlled
substance. Mr. Stabile was given notice
of the proposed debarment and was
given an opportunity to request a
hearing to show why he should not be
debarred. As of June 7, 2024 (30 days
after receipt of the notice), Mr. Stabile
had not responded. Mr. Stabile’s failure
to respond and request a hearing
constitutes a waiver of his right to a
hearing concerning this matter.
DATES: This order is applicable August
15, 2024.
ADDRESSES: Any application by Mr.
Stabile for termination of debarment
under section 306(d)(1) of the FD&C Act
(21 U.S.C. 335a(d)(1)) may be submitted
at any time as follows:
SUMMARY:
Electronic Submissions
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
An application submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
application will be made public, you are
solely responsible for ensuring that your
application does not include any
E:\FR\FM\15AUN1.SGM
15AUN1
]]>Agencies
[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]
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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.
-----------------------------------------------------------------------
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]
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