Notice2023-11991
Vintage Pharmaceuticals; Withdrawal of Approval of Abbreviated New Drug Application for Pemoline Tablets, 18.75 Milligrams, 37.5 Milligrams, and 75 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
June 6, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is withdrawing approval of abbreviated new drug application (ANDA) 075328 for pemoline tablets, 18.75 milligrams (mg), 37.5 mg, and 75 mg, held by Vintage Pharmaceuticals, 120 Vintage Dr., Huntsville, AL 35811 (Vintage). Vintage requested that approval of this application be withdrawn and has waived its opportunity for a hearing.
Full Text
<html>
<head>
<title>Federal Register, Volume 88 Issue 108 (Tuesday, June 6, 2023)</title>
</head>
<body><pre>
[Federal Register Volume 88, Number 108 (Tuesday, June 6, 2023)]
[Notices]
[Pages 37068-37069]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-11991]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-2008]
Vintage Pharmaceuticals; Withdrawal of Approval of Abbreviated
New Drug Application for Pemoline Tablets, 18.75 Milligrams, 37.5
Milligrams, and 75 Milligrams
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is
withdrawing approval of abbreviated new drug application (ANDA) 075328
for pemoline tablets, 18.75 milligrams (mg), 37.5 mg, and 75 mg, held
by Vintage Pharmaceuticals, 120 Vintage Dr., Huntsville, AL 35811
(Vintage). Vintage requested that approval of this application be
withdrawn and has waived its opportunity for a hearing.
DATES: Approval is withdrawn as of June 6, 2023.
FOR FURTHER INFORMATION CONTACT: Kimberly Lehrfeld, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
[[Page 37069]]
Hampshire Ave., Bldg. 51, Rm. 6226, Silver Spring, MD 20993, 301-796-
3137, <a href="/cdn-cgi/l/email-protection#03486a6e6166716f7a2d4f666b7165666f67436567622d6b6b702d646c75"><span class="__cf_email__" data-cfemail="541f3d39363126382d7a18313c2632313830143230357a3c3c277a333b22">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: On April 19, 2000, FDA approved ANDA 075328
for pemoline tablets, 18.75 mg, 37.5 mg, and 75 mg, for the conditions
of use in the labeling of new drug application (NDA) 016832, the
reference listed drug on which it relied. On October 24, 2005, the
Agency 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 Vintage, ceased marketing the products at that time. On June
21, 2012, Vintage requested that FDA withdraw approval of ANDA 075328,
pursuant to Sec. 314.150(d) (21 CFR 314.150(d)) and waived its
opportunity for a hearing. Vintage stated in its June 21, 2012, request
for withdrawal of approval of ANDA 075328 that it had discontinued
manufacturing the product since April 2005.
In the Federal Register issue of July 19, 2013 (78 FR 43210), FDA
erroneously included ANDA 075328 in a list of drug applications for
which approval was being withdrawn under Sec. 314.150(c). In a
separate notice published in this issue of the Federal Register, FDA
corrected the July 19, 2013, notice to remove ANDA 075328 from the list
of applications whose approval was withdrawn under Sec. 314.150(c).
For the reasons discussed above, and in accordance with the
applicant's request, approval of ANDA 075328 for pemoline tablets,
18.75 mg, 37.5 mg, and 75 mg, and all amendments and supplements
thereto, is withdrawn under Sec. 314.150(d). Distribution of pemoline
tablets, 18.75 mg, 37.5 mg, and 75 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 (21 U.S.C. 355(a) and 331(d)).
Dated: May 31, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-11991 Filed 6-5-23; 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 June 6, 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.