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
| Published date | 23 May 2023 |
| Record Number | 2023-10924 |
| Citation | 88 FR 33148 |
| Court | Food And Drug Administration |
| Section | Notices |
33148
Federal Register / Vol. 88, No. 99 / Tuesday, May 23, 2023 / Notices
E
STIMATED
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URDEN
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OURS
Type of respondents Form name Number of
respondents
Number of
responses per
respondent
Average
burden per
response
(in hours)
Individuals (male and female) aged 18 years and older ........ Study Screener ...................... 30,880 1 2/60
Survey Module ....................... 5,445 1 30/60
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.
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applications be withdrawn and has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: Approval is withdrawn as of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, 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
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))).
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
AGENCY
: Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION
: Notice.
SUMMARY
: 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.
DATES
: 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
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