Pharmacyclics LLC.; Withdrawal of Approval of Indications for Mantle Cell Lymphoma and Marginal Zone Lymphoma for IMBRUVICA (ibrutinib) Capsules and Tablets, 87435 [2023-27662]
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Federal Register / Vol. 88, No. 241 / Monday, December 18, 2023 / Notices
Dated: December 11, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–27655 Filed 12–15–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–N–5344]
Pharmacyclics LLC.; Withdrawal of
Approval of Indications for Mantle Cell
Lymphoma and Marginal Zone
Lymphoma for IMBRUVICA (ibrutinib)
Capsules and Tablets
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing that it is withdrawing
approval of the indications for mantle
cell lymphoma (MCL) and marginal
zone lymphoma (MZL) for IMBRUVICA
(ibrutinib) Capsules and Tablets
approved, respectively, under new drug
applications (NDAs) 205552 and
210563. These NDAs are held by
Pharmacyclics LLC, 1000 Gateway
Blvd., South San Francisco, CA 94080
(Pharmacyclics). Pharmacyclics
voluntarily requested that the Agency
withdraw approval of these indications
and waived its opportunity for a
hearing.
DATES: Approval is withdrawn as of
December 18, 2023.
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.
SUPPLEMENTARY INFORMATION: On
November 13, 2013, FDA approved
NDA 205552 for IMBRUVICA (ibrutinib)
Capsules for the treatment of adult
patients with MCL who have received at
least one prior therapy (the MCL
indication). On January 18, 2017, FDA
approved a prior approval supplement
for NDA 205552 for IMBRUVICA
(ibrutinib) Capsules for the treatment of
adult patients with MZL who require
systemic therapy and have received at
least one prior anti-CD20-based therapy
(the MZL indication). On February 16,
2018, FDA approved NDA 210563 for
IMBRUVICA (ibrutinib) Tablets, a new
dosage form of IMBRUVICA (ibrutinib),
for the MCL and MZL indications. FDA
khammond on DSKJM1Z7X2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
17:41 Dec 15, 2023
Jkt 262001
approved the MCL and MZL indications
for both products under the Agency’s
accelerated approval regulations, 21
CFR part 314, subpart H. As a condition
of accelerated approval of IMBRUVICA
(ibrutinib) Capsules and Tablets for the
MCL and MZL indications, the
applicant was required to conduct
postmarketing trials to verify the
clinical benefit of ibrutinib for the MCL
and MZL indications.
On February 8, 2023, FDA met with
Pharmacyclics to inform the applicant
of the plans to convene the Oncologic
Drugs Advisory Committee regarding
the accelerated approvals for the MCL
and MZL indications because the
required postmarketing trials did not
verify the clinical benefit of ibrutinib for
these indications. On March 21, 2023,
FDA met with Pharmacyclics to discuss
the applicant’s request to voluntarily
withdraw approval of the MCL and MZL
indications for IMBRUVICA (ibrutinib)
Capsules and Tablets. On April 6, 2023,
Pharmacyclics submitted a letter
requesting withdrawal of the MCL and
MZL indications for IMBRUVICA
(ibrutinib) Capsules and Tablets
pursuant to § 314.150(d) (21 CFR
314.150(d)) and waiving its opportunity
for a hearing.
Therefore, under § 314.150(d),
approvals of the MCL and MZL
indications for IMBRUVICA (ibrutinib)
Capsules and Tablets are withdrawn as
of December 18, 2023. Withdrawal of
approval of these indications does not
affect any other approved indication for
IMBRUVICA (ibrutinib) Capsules and
Tablets.
Dated: December 12, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–27662 Filed 12–15–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Indian Health Service
Funding Opportunity for the
Community Opioid Intervention
Prevention Program
Announcement Type: New.
Funding Announcement Number:
HHS–2024–IHS–COIPP–0001.
Assistance Listing (Catalog of Federal
Domestic Assistance or CFDA) Number:
93.654.
Key Dates
Application Deadline Date: February
7, 2024.
Earliest Anticipated Start Date: April
1, 2024.
PO 00000
Frm 00051
Fmt 4703
Sfmt 4703
87435
I. Funding Opportunity Description
Statutory Authority
The Indian Health Service (IHS),
Office of Clinical and Preventive
Services, Division of Behavioral Health
(DBH) is accepting applications for
grants for the Community Opioid
Intervention Prevention Program
(COIPP). This program is authorized
under the Snyder Act, 25 U.S.C. 13, and
the Transfer Act, 42 U.S.C. 2001(a).
Funding for this program is provided in
the Consolidated Appropriations Act,
2023, Public Law 117–328, 136 Stat.
4459, 4808 (2022). The Assistance
Listings section of SAM.gov (https://
sam.gov/content/home) describes this
program under 93.654.
Background
The initial opioid prevention
program, called the Community Opioid
Intervention Pilot Project, was first
established in Fiscal Year (FY) 2019,
pursuant to Congressional instruction to
better combat the opioid epidemic. The
goal was to create a pilot program to
address the opioid epidemic in Indian
Country and award grants that
supported the development,
documentation, and sharing of locally
designed and culturally appropriate
prevention, treatment, recovery, and
aftercare services for opioid use
disorders in the American Indian and
Alaska Native (AI/AN) communities.
Evidence-based activities are available
for reference at https://www.ihs.gov/
asap/coipp/. A total of 35 grants were
awarded to Tribal and Urban Indian
communities in the pilot phase. Based
on evaluation results from the pilot
project, this funding opportunity will
continue to provide grant support to
Tribal and Urban Indian communities to
continue efforts to combat the opioid
epidemic and develop strategies that
align with the Department of Health and
Human Services Overdose Prevention
Strategy.
The Centers for Disease Control and
Prevention (CDC) reported that the AI/
AN population had the highest drug
overdose death rates in both 2020 and
2021, at rates of 42.5 and 56.6 deaths
per 100,000 persons, respectively. The
AI/AN population also experienced a 33
percent increase in drug overdose
deaths from 2020 through 2021.
Overdose deaths among AI/AN have
continued to increase over the last 20
years. The CDC reported from 2019 to
2020, overdose death rates increased 39
percent for the non-Hispanic AI/AN
population and drug overdose death
rates were highest for AI/AN people
compared to other racial and ethnic
groups.
E:\FR\FM\18DEN1.SGM
18DEN1
]]>Agencies
[Federal Register Volume 88, Number 241 (Monday, December 18, 2023)]
[Notices]
[Page 87435]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-27662]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-5344]
Pharmacyclics LLC.; Withdrawal of Approval of Indications for
Mantle Cell Lymphoma and Marginal Zone Lymphoma for IMBRUVICA
(ibrutinib) Capsules and Tablets
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
that it is withdrawing approval of the indications for mantle cell
lymphoma (MCL) and marginal zone lymphoma (MZL) for IMBRUVICA
(ibrutinib) Capsules and Tablets approved, respectively, under new drug
applications (NDAs) 205552 and 210563. These NDAs are held by
Pharmacyclics LLC, 1000 Gateway Blvd., South San Francisco, CA 94080
(Pharmacyclics). Pharmacyclics voluntarily requested that the Agency
withdraw approval of these indications and waived its opportunity for a
hearing.
DATES: Approval is withdrawn as of December 18, 2023.
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: On November 13, 2013, FDA approved NDA
205552 for IMBRUVICA (ibrutinib) Capsules for the treatment of adult
patients with MCL who have received at least one prior therapy (the MCL
indication). On January 18, 2017, FDA approved a prior approval
supplement for NDA 205552 for IMBRUVICA (ibrutinib) Capsules for the
treatment of adult patients with MZL who require systemic therapy and
have received at least one prior anti-CD20-based therapy (the MZL
indication). On February 16, 2018, FDA approved NDA 210563 for
IMBRUVICA (ibrutinib) Tablets, a new dosage form of IMBRUVICA
(ibrutinib), for the MCL and MZL indications. FDA approved the MCL and
MZL indications for both products under the Agency's accelerated
approval regulations, 21 CFR part 314, subpart H. As a condition of
accelerated approval of IMBRUVICA (ibrutinib) Capsules and Tablets for
the MCL and MZL indications, the applicant was required to conduct
postmarketing trials to verify the clinical benefit of ibrutinib for
the MCL and MZL indications.
On February 8, 2023, FDA met with Pharmacyclics to inform the
applicant of the plans to convene the Oncologic Drugs Advisory
Committee regarding the accelerated approvals for the MCL and MZL
indications because the required postmarketing trials did not verify
the clinical benefit of ibrutinib for these indications. On March 21,
2023, FDA met with Pharmacyclics to discuss the applicant's request to
voluntarily withdraw approval of the MCL and MZL indications for
IMBRUVICA (ibrutinib) Capsules and Tablets. On April 6, 2023,
Pharmacyclics submitted a letter requesting withdrawal of the MCL and
MZL indications for IMBRUVICA (ibrutinib) Capsules and Tablets pursuant
to Sec. 314.150(d) (21 CFR 314.150(d)) and waiving its opportunity for
a hearing.
Therefore, under Sec. 314.150(d), approvals of the MCL and MZL
indications for IMBRUVICA (ibrutinib) Capsules and Tablets are
withdrawn as of December 18, 2023. Withdrawal of approval of these
indications does not affect any other approved indication for IMBRUVICA
(ibrutinib) Capsules and Tablets.
Dated: December 12, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-27662 Filed 12-15-23; 8:45 am]
BILLING CODE 4164-01-P
