84 FR 192 pgs. 52887-52888 - Teva Pharmaceuticals USA, Inc., et al.; Withdrawal of Approval of Five Abbreviated New Drug Applications for Pemoline Products; Correction
Type: NOTICEVolume: 84Number: 192Pages: 52887 - 52888
Pages: 52887, 52888Docket number: [Docket No. FDA-2019-N-1707]
FR document: [FR Doc. 2019-21526 Filed 10-2-19; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
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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.
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:
[top] Kimberly Lehrfeld, Center for Drug
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