Notice2023-10924
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
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
May 23, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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 Abbott requested that approval of these applications be withdrawn and has waived its opportunity for a hearing.
Full Text
<html>
<head>
<title>Federal Register, Volume 88 Issue 99 (Tuesday, May 23, 2023)</title>
</head>
<body><pre>
[Federal Register Volume 88, Number 99 (Tuesday, May 23, 2023)]
[Notices]
[Page 33148]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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withdrawn and has waived its opportunity for a hearing.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, <a href="/cdn-cgi/l/email-protection#b3f8daded1d6c1dfca9dffd6dbc1d5d6dfd7f3d5d7d29ddbdbc09dd4dcc5"><span class="__cf_email__" data-cfemail="692200040b0c1b051047250c011b0f0c050d290f0d084701011a470e061f">[email protected]</span></a>.
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 (<a href="https://wayback.archive-it.org/7993/20171114124349/https://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm126461.htm">https://wayback.archive-it.org/7993/20171114124349/https://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm126461.htm</a>).
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
</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>Indexed from Federal Register on May 23, 2023.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.