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

• Published date: 03 October 2019
• Record Number: 2019-21526
• Section: Notices
• Court: Food And Drug Administration

Federal Register, Volume 84 Issue 192 (Thursday, October 3, 2019)

[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