Document ID: FDA-2019-N-1707-0002
Agency: fda
Document Type: Notice
Title: Teva Pharmaceuticals USA, Inc., et al.; Withdrawal of Approval of Five
Abbreviated New Drug Applications for Pemoline Products; Correction
Posted Date: 2019-10-03T04:00Z

[Federal Register Volume 84, Number 192 (Thursday, October 3, 2019)]
[Notices]
[Pages 52887-52888]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-21526]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-1707]

Teva Pharmaceuticals USA, Inc., et al.; Withdrawal of Approval of 
Five Abbreviated New Drug Applications for Pemoline Products; 
Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; correction.

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SUMMARY: The Food and Drug Administration (FDA) is correcting a notice 
that appeared in the Federal Register of June 4, 2019. That notice, 
withdrawing approval of five abbreviated new drug applications for 
pemoline products, contained an incorrect website address for an 
archived web page of a Postmarket Drug Safety Information for 
Healthcare Professionals communication that FDA issued on October 24, 
2005, stating its conclusion that the overall liver toxicity risk of 
CYLERT (new drug applications 016832 and 017703) and generic pemoline 
products outweighed the benefits of these products. This document 
corrects that error.

FOR FURTHER INFORMATION CONTACT: Kimberly Lehrfeld, Center for Drug

[[Page 52888]]

Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6226, Silver Spring, MD 20993-0002, 301-
796-3137.

SUPPLEMENTARY INFORMATION: In the Federal Register of June 4, 2019 (84 
FR 25811), appearing on page 25811 in FR Doc. 2019-11519, the following 
correction is made:
    On page 25811, in the last paragraph of the third column, the 
website address, https://wayback.archiveit.org/7993/20171114124349/https://www.fda.gov/DrugsDrugSafety/PostmarketDrugSafetyinformationforPatientsandProviders/ucm126461.htm, 
is corrected to read https://wayback.archive-it.org/7993/20171114124349/https://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm126461.htm.

    Dated: September 27, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-21526 Filed 10-2-19; 8:45 am]
BILLING CODE 4164-01-P