Document ID: FDA-2023-N-2008-0001
Agency: fda
Document Type: Notice
Title: Vintage Pharmaceuticals; Withdrawal of Approval of Abbreviated New Drug
Application for Pemoline Tablets, 18.75 Milligrams, 37.5 Milligrams, and 75
Milligrams
Posted Date: 2023-06-06T04:00Z

[Federal Register Volume 88, Number 108 (Tuesday, June 6, 2023)]
[Notices]
[Pages 37068-37069]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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withdrawn and has waived its opportunity for a hearing.

DATES: Approval is withdrawn as of June 6, 2023.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, [email protected].

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 (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 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