[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]


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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.

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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withdrawn and has waived its opportunity for a hearing.

DATES: Approval is withdrawn as of May 23, 2023.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