Teva Branded Pharmaceutical Products R&D, Inc.; Withdrawal of Approval of a New Drug Application for ZECUITY (Sumatriptan Iontophoretic Transdermal System), 39913 [2020-14284]

Download as PDF Federal Register / Vol. 85, No. 128 / Thursday, July 2, 2020 / Notices Jeffrey M. Zirger, Lead, Information Collection Review Office, Office of Scientific Integrity, Office of Science, Centers for Disease Control and Prevention. [FR Doc. 2020–14332 Filed 7–1–20; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2020–N–1360] Teva Branded Pharmaceutical Products R&D, Inc.; Withdrawal of Approval of a New Drug Application for ZECUITY (Sumatriptan Iontophoretic Transdermal System) AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is withdrawing the approval of the new drug application (NDA) for ZECUITY (sumatriptan iontophoretic transdermal system) held by Teva Branded Pharmaceutical Products R&D, Inc. (Teva), 41 Moores Rd., P.O. Box 4011, Frazer, PA 19355. Teva requested withdrawal of this application and has waived its opportunity for a hearing. DATES: Approval is withdrawn as of July 2, 2020. FOR FURTHER INFORMATION CONTACT: Kimberly Lehrfeld, Center for Drug 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: On January 17, 2013, FDA approved NDA 202278 for ZECUITY (sumatriptan iontophoretic transdermal system) for the acute treatment of migraine with or without aura in adults. On June 2, 2016, FDA issued a Drug Safety Communication announcing the FDA is investigating the risk of serious burns and potential permanent scarring with the use of ZECUITY for migraine headaches. (https://www.fda.gov/drugs/ drug-safety-and-availability/fda-drugsafety-communication-fda-evaluatingrisk-burns-and-scars-ZECUITYsumatriptan-migraine-patch). On June 10, 2016, Teva suspended sales, marketing and distribution to investigate the cause of burns and scars associated with ZECUITY. On July 19, 2019, Teva requested withdrawal of NDA 202278 for ZECUITY under § 314.150(d) (21 CFR 314.150(d)) and waived its opportunity for a hearing. In its letter requesting khammond on DSKJM1Z7X2PROD with NOTICES SUMMARY: VerDate Sep<11>2014 21:18 Jul 01, 2020 Jkt 250001 withdrawal of approval, Teva stated that it voluntarily discontinued manufacture and sale of products under NDA 202278 in 2016 for commercial reasons and has agreed to withdrawal of the application for those reasons only. For the reasons discussed above, and pursuant to the applicant’s request, approval of NDA 202278 for ZECUITY (sumatriptan iontophoretic transdermal system), and all amendments and supplements thereto, is withdrawn under § 314.150(d). Distribution of ZECUITY 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: June 22, 2020. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2020–14284 Filed 7–1–20; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2010–N–0583] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Radioactive Drug Research Committees AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. DATES: Submit written comments (including recommendations) on the collection of information by August 3, 2020. ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be submitted to www.reginfo.gov/public/do/PRAMain. Find this particular information collection by selecting ‘‘Currently under Review—Open for Public Comments’’ or by using the search function. The OMB control number for this information collection is 0910–0053. Also include the FDA docket number found in brackets in the heading of this document. SUMMARY: PO 00000 Frm 00045 Fmt 4703 Sfmt 4703 39913 Ila S. Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 10A–12M, 11601 Landsdown St., North Bethesda, MD 20852, 301–796–7726, PRAStaff@ fda.hhs.gov. SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. FOR FURTHER INFORMATION CONTACT: Radioactive Drug Research Committees—21 CFR 361.1 OMB Control Number 0910–0053— Extension Under sections 201, 505, and 701 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 355, and 371), FDA has the authority to issue regulations governing the use of radioactive drugs for basic scientific research. This information collection request supports those regulations. Specifically, § 361.1 (21 CFR 361.1) sets forth specific regulations about establishing and composing radioactive drug research committees (RDRCs) and their role in approving and monitoring basic research studies using radiopharmaceuticals. No basic research study involving any administration of a radioactive drug to research subjects is permitted without the authorization of an FDA-approved RDRC (§ 361.1(d)(7)). The type of research that may be undertaken with a radiopharmaceutical drug must be intended to obtain basic information and not to carry out a clinical trial for safety or efficacy. The types of basic research permitted are specified in the regulations and include studies of metabolism, human physiology, pathophysiology, or biochemistry. Section 361.1(c)(2) requires that each RDRC will select a chairman, who will sign all applications, minutes, and reports of the committee. Each committee will meet at least once each quarter in which research activity has been authorized or conducted. Minutes will be kept and will include the numerical results of votes on protocols involving use in human subjects. Under § 361.1(c)(3), each RDRC will submit an annual report to FDA. The annual report will include the names and qualifications of the members of and of any consultants used by the RDRC, using Form FDA 2914 entitled ‘‘Radioactive Drug Research Committee Report on Research Use of Radioactive Drugs Membership Summary.’’ The annual report will also include a summary of each study conducted during the preceding year, using Form E:\FR\FM\02JYN1.SGM 02JYN1

Agencies

[Federal Register Volume 85, Number 128 (Thursday, July 2, 2020)]
[Notices]
[Page 39913]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-14284]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-1360]


Teva Branded Pharmaceutical Products R&D, Inc.; Withdrawal of 
Approval of a New Drug Application for ZECUITY (Sumatriptan 
Iontophoretic Transdermal System)

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is withdrawing the 
approval of the new drug application (NDA) for ZECUITY (sumatriptan 
iontophoretic transdermal system) held by Teva Branded Pharmaceutical 
Products R&D, Inc. (Teva), 41 Moores Rd., P.O. Box 4011, Frazer, PA 
19355. Teva requested withdrawal of this application and has waived its 
opportunity for a hearing.

DATES: Approval is withdrawn as of July 2, 2020.

FOR FURTHER INFORMATION CONTACT: Kimberly Lehrfeld, Center for Drug 
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: On January 17, 2013, FDA approved NDA 202278 
for ZECUITY (sumatriptan iontophoretic transdermal system) for the 
acute treatment of migraine with or without aura in adults. On June 2, 
2016, FDA issued a Drug Safety Communication announcing the FDA is 
investigating the risk of serious burns and potential permanent 
scarring with the use of ZECUITY for migraine headaches. (https://www.fda.gov/drugs/drug-safety-and-availability/fda-drug-safety-communication-fda-evaluating-risk-burns-and-scars-ZECUITY-sumatriptan-migraine-patch). On June 10, 2016, Teva suspended sales, marketing and 
distribution to investigate the cause of burns and scars associated 
with ZECUITY.
    On July 19, 2019, Teva requested withdrawal of NDA 202278 for 
ZECUITY under Sec.  314.150(d) (21 CFR 314.150(d)) and waived its 
opportunity for a hearing. In its letter requesting withdrawal of 
approval, Teva stated that it voluntarily discontinued manufacture and 
sale of products under NDA 202278 in 2016 for commercial reasons and 
has agreed to withdrawal of the application for those reasons only.
    For the reasons discussed above, and pursuant to the applicant's 
request, approval of NDA 202278 for ZECUITY (sumatriptan iontophoretic 
transdermal system), and all amendments and supplements thereto, is 
withdrawn under Sec.  314.150(d).
    Distribution of ZECUITY 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: June 22, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-14284 Filed 7-1-20; 8:45 am]
BILLING CODE 4164-01-P

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