Document ID: FDA-2023-N-0680-0001
Agency: fda
Document Type: Notice
Title: Fosun Pharma USA Inc.; Withdrawal of Approval of Abbreviated New Drug Application for Pemoline Tablets, 18.75 Milligrams, 37.5 Milligrams, and 75 Milligrams
Posted Date: 2023-03-07T05:00Z

[Federal Register Volume 88, Number 44 (Tuesday, March 7, 2023)]
[Notices]
[Pages 14171-14172]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-04564]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-N-0680]

Fosun Pharma USA Inc.; 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.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is 
withdrawing approval of abbreviated new drug application (ANDA) 075286 
for pemoline tablets, 18.75 milligrams (mg), 37.5 mg, and 75 mg, held 
by Fosun Pharma USA Inc. (Fosun), 104 Carnegie Center, Princeton, NJ 
08540. Fosun requested that approval of this application be withdrawn 
and has waived its opportunity for a hearing.

DATES: Approval is withdrawn as of March 7, 2023.

FOR FURTHER INFORMATION CONTACT: Kimberly Lehrfeld, Office of 
Regulatory Policy, Center for Drug Evaluation and Research, Food and 
Drug Administration, 10903 New Hampshire

[[Page 14172]]

Ave., Bldg. 51, Rm. 6226, Silver Spring, MD 20993, 301-796-3137, 
[email protected].

SUPPLEMENTARY INFORMATION: On June 30, 1999, FDA approved ANDA 075286 
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 Fosun, ceased marketing the products at that time. On April 
22, 2019, Fosun requested that FDA withdraw approval of ANDA 075286, 
pursuant to Sec.  314.150(d) (21 CFR 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 ANDA 075286 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: March 1, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-04564 Filed 3-6-23; 8:45 am]
BILLING CODE 4164-01-P