Abbott Laboratories Pharmaceutical Products Division; Withdrawal of Approval of New Drug Applications for CYLERT (Pemoline) Tablets, 18.75 Milligrams, 37.5 Milligrams, and 75 Milligrams, and CYLERT (Pemoline) Chewable Tablets, 37.5 Milligrams, 33148 [2023-10924]
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33148
Federal Register / Vol. 88, No. 99 / Tuesday, May 23, 2023 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS
Form name
Individuals (male and female) aged 18 years and older ........
Study Screener ......................
Survey Module .......................
Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Public Health Ethics and
Regulations, Office of Science, Centers for
Disease Control and Prevention.
[FR Doc. 2023–10957 Filed 5–22–23; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–N–0687]
Abbott Laboratories Pharmaceutical
Products Division; Withdrawal of
Approval of New Drug Applications for
CYLERT (Pemoline) Tablets, 18.75
Milligrams, 37.5 Milligrams, and 75
Milligrams, and CYLERT (Pemoline)
Chewable Tablets, 37.5 Milligrams
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
withdrawing approval of new drug
application (NDA) 016832 for CYCLERT
(pemoline) tablets, 18.75 milligrams
(mg), 37.5 mg, and 75 mg, as well as
NDA 017703 for CYCLERT (pemoline)
chewable tablets, 37.5 mg, held by
Abbott Laboratories Pharmaceutical
Products Division, c/o G&L Scientific,
25 Independence Blvd., 4th Floor,
Warren, NJ 07059 (Abbott). Abbott
requested that approval of these
applications be withdrawn and has
waived its opportunity for a hearing.
DATES: Approval is withdrawn as of
May 23, 2023.
FOR FURTHER INFORMATION CONTACT:
Kimberly Lehrfeld, Office of Regulatory
Policy, Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, Rm. 6226, Silver Spring,
MD 20993, 301–796–3137, Kimberly.
Lehrfeld@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: On
January 27, 1975, FDA approved NDA
016832 for CYLERT (pemoline) tablets,
18.75 mg, 37.5 mg, and 75 mg, for use
in the treatment of Attention-Deficit/
Hyperactivity Disorder (ADHD). On
SUMMARY:
lotter on DSK11XQN23PROD with NOTICES1
Number of
respondents
Type of respondents
VerDate Sep<11>2014
17:24 May 22, 2023
Jkt 259001
January 30, 1976, the Agency approved
NDA 017703 for CYLERT (pemoline)
chewable tablets, 37.5 mg, for use in the
treatment of ADHD. On October 24,
2005, FDA issued a Postmarket Drug
Safety Information for Patients and
Providers communication entitled
‘‘Information for Healthcare
Professionals: Pemoline Tablets and
Chewable Tablets (Marketed as
CYLERT)’’ which concluded the overall
liver toxicity risk of CYLERT (pemoline)
(NDAs 016832 and 017703) and generic
pemoline products outweighed the
benefits of these products (https://
wayback.archive-it.org/7993/
20171114124349/https://www.fda.gov/
Drugs/DrugSafety/Postmarket
DrugSafetyInformationforPatientsand
Providers/ucm126461.htm).
All holders of approved applications
for pemoline products, including
Abbott, ceased marketing the products
at that time. On April 12, 2021, FDA
contacted Abbott and requested the
company submit a request for FDA to
withdraw approval of NDAs 016832 and
017703 for CYLERT tablets and CYLERT
chewable tablets, respectively, pursuant
to § 314.150(d) (21 CFR 314.150(d)) due
to the risk of liver toxicity. On
September 2, 2021, Abbott requested
that FDA withdraw approval of CYLERT
(pemoline) tablets and CYLERT
(pemoline) chewable tablets, NDAs
016832 and 017703, respectively, under
§ 314.150(d) and waived its opportunity
for a hearing.
For the reasons discussed above, and
in accordance with the applicant’s
request, approval of NDAs 016832 and
017703 for CYLERT (pemoline) tablets,
18.75 mg, 37.5 mg, and 75 mg, and
CYLERT (pemoline) chewable tablets,
37.5 mg, respectively, and all
amendments and supplements thereto,
is withdrawn under § 314.150(d).
Distribution of CYLERT (pemoline)
tablets, 18.75 mg, 37.5 mg, and 75 mg,
and CYLERT (pemoline) chewable
tablets, 37.5 mg, into interstate
commerce without an approved
application is illegal and subject to
regulatory action (see sections 505(a)
and 301(d) of the Federal Food, Drug,
and Cosmetic Act (FD&C Act) (21 U.S.C.
355(a) and 331(d))).
PO 00000
Frm 00069
Fmt 4703
Sfmt 4703
Number of
responses per
respondent
30,880
5,445
Average
burden per
response
(in hours)
1
1
2/60
30/60
Dated: May 17, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–10924 Filed 5–22–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Submission to OMB for
Review and Approval; Public Comment
Request; Nurse Faculty Loan
Program—Program Specific Data
Form, Annual Performance Report
Financial Data Form and NFLP Due
Diligence Form; OMB No. 0915–0314–
Revision
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:
In compliance with the
Paperwork Reduction Act of 1995,
HRSA submitted an Information
Collection Request (ICR) to the Office of
Management and Budget (OMB) for
review and approval. Comments
submitted during the first public review
of this ICR will be provided to OMB.
OMB will accept further comments from
the public during the review and
approval period. OMB may act on
HRSA’s ICR only after the 30-day
comment period for this notice has
closed.
SUMMARY:
Comments on this ICR should be
received no later than June 22, 2023.
ADDRESSES: Written comments and
recommendations for the proposed
information collection should be sent
within 30 days of publication of this
notice to www.reginfo.gov/public/do/
PRAMain. Find this particular
information collection by selecting
‘‘Currently under Review—Open for
Public Comments’’ or by using the
search function.
FOR FURTHER INFORMATION CONTACT: To
request a copy of the clearance requests
submitted to OMB for review, email
Samantha Miller, the HRSA Information
DATES:
E:\FR\FM\23MYN1.SGM
23MYN1
]]>Agencies
[Federal Register Volume 88, Number 99 (Tuesday, May 23, 2023)]
[Notices]
[Page 33148]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-10924]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-0687]
Abbott Laboratories Pharmaceutical Products Division; Withdrawal
of Approval of New Drug Applications for CYLERT (Pemoline) Tablets,
18.75 Milligrams, 37.5 Milligrams, and 75 Milligrams, and CYLERT
(Pemoline) Chewable Tablets, 37.5 Milligrams
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is
withdrawing approval of new drug application (NDA) 016832 for CYCLERT
(pemoline) tablets, 18.75 milligrams (mg), 37.5 mg, and 75 mg, as well
as NDA 017703 for CYCLERT (pemoline) chewable tablets, 37.5 mg, held by
Abbott Laboratories Pharmaceutical Products Division, c/o G&L
Scientific, 25 Independence Blvd., 4th Floor, Warren, NJ 07059
(Abbott). Abbott requested that approval of these applications be
withdrawn and has waived its opportunity for a hearing.
DATES: Approval is withdrawn as of May 23, 2023.
FOR FURTHER INFORMATION CONTACT: Kimberly Lehrfeld, Office of
Regulatory Policy, Center for Drug Evaluation and Research, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6226,
Silver Spring, MD 20993, 301-796-3137, [email protected].
SUPPLEMENTARY INFORMATION: On January 27, 1975, FDA approved NDA 016832
for CYLERT (pemoline) tablets, 18.75 mg, 37.5 mg, and 75 mg, for use in
the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD). On
January 30, 1976, the Agency approved NDA 017703 for CYLERT (pemoline)
chewable tablets, 37.5 mg, for use in the treatment of ADHD. On October
24, 2005, FDA issued a Postmarket Drug Safety Information for Patients
and Providers communication entitled ``Information for Healthcare
Professionals: Pemoline Tablets and Chewable Tablets (Marketed as
CYLERT)'' which concluded the overall liver toxicity risk of CYLERT
(pemoline) (NDAs 016832 and 017703) and generic pemoline products
outweighed the benefits of these products (https://wayback.archive-it.org/7993/20171114124349/https://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm126461.htm).
All holders of approved applications for pemoline products,
including Abbott, ceased marketing the products at that time. On April
12, 2021, FDA contacted Abbott and requested the company submit a
request for FDA to withdraw approval of NDAs 016832 and 017703 for
CYLERT tablets and CYLERT chewable tablets, respectively, pursuant to
Sec. 314.150(d) (21 CFR 314.150(d)) due to the risk of liver toxicity.
On September 2, 2021, Abbott requested that FDA withdraw approval of
CYLERT (pemoline) tablets and CYLERT (pemoline) chewable tablets, NDAs
016832 and 017703, respectively, under Sec. 314.150(d) and waived its
opportunity for a hearing.
For the reasons discussed above, and in accordance with the
applicant's request, approval of NDAs 016832 and 017703 for CYLERT
(pemoline) tablets, 18.75 mg, 37.5 mg, and 75 mg, and CYLERT (pemoline)
chewable tablets, 37.5 mg, respectively, and all amendments and
supplements thereto, is withdrawn under Sec. 314.150(d). Distribution
of CYLERT (pemoline) tablets, 18.75 mg, 37.5 mg, and 75 mg, and CYLERT
(pemoline) chewable tablets, 37.5 mg, into interstate commerce without
an approved application is illegal and subject to regulatory action
(see sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic
Act (FD&C Act) (21 U.S.C. 355(a) and 331(d))).
Dated: May 17, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-10924 Filed 5-22-23; 8:45 am]
BILLING CODE 4164-01-P
