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DATES: Approval is withdrawn as of July 2, 2020.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


