Teva Pharmaceuticals USA, Inc., et al.; Withdrawal of Approval of 15 Abbreviated New Drug Applications; Correction

Issuing agencies

Abstract

The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register on May 7, 2026. The document announced the withdrawal of approval of 15 abbreviated new drug applications (ANDAs) from multiple applicants, withdrawn as of June 8, 2026. The document indicated that FDA was withdrawing approval of ANDA 210285 for dimethyl fumarate delayed-release capsule, 120 milligrams (mg) and 240 mg, held by Upsher-Smith Laboratories, LLC., U.S. Agent for Sawai USA, Inc., 6701 Evenstad Dr. N, Suite 300, Maple Grove, MN 55369. Before FDA withdrew the approval of this ANDA, Upsher-Smith Laboratories, LLC., U.S. Agent for Sawai USA, Inc., informed FDA that they did not want the approval of the ANDA withdrawn. Because Upsher- Smith Laboratories, LLC., U.S. Agent for Sawai USA, Inc., timely requested that approval of the ANDA not be withdrawn, the approval is still in effect. This notice removes the entry for ANDA 210285.

Full Text

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<title>Federal Register, Volume 91 Issue 192 (Tuesday, October 6, 2026)</title>
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[Federal Register Volume 91, Number 192 (Tuesday, October 6, 2026)]
[Notices]
[Page 63569]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-20460]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2026-N-4291]


Teva Pharmaceuticals USA, Inc., et al.; Withdrawal of Approval of 
15 Abbreviated New Drug Applications; 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 on May 7, 2026. The document 
announced the withdrawal of approval of 15 abbreviated new drug 
applications (ANDAs) from multiple applicants, withdrawn as of June 8, 
2026. The document indicated that FDA was withdrawing approval of ANDA 
210285 for dimethyl fumarate delayed-release capsule, 120 milligrams 
(mg) and 240 mg, held by Upsher-Smith Laboratories, LLC., U.S. Agent 
for Sawai USA, Inc., 6701 Evenstad Dr. N, Suite 300, Maple Grove, MN 
55369. Before FDA withdrew the approval of this ANDA, Upsher-Smith 
Laboratories, LLC., U.S. Agent for Sawai USA, Inc., informed FDA that 
they did not want the approval of the ANDA withdrawn. Because Upsher-
Smith Laboratories, LLC., U.S. Agent for Sawai USA, Inc., timely 
requested that approval of the ANDA not be withdrawn, the approval is 
still in effect. This notice removes the entry for ANDA 210285.

FOR FURTHER INFORMATION CONTACT: Martha Nguyen, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 75, Rm. 1676, Silver Spring, MD 20993-0002, 301-
796-3471, <a href="/cdn-cgi/l/email-protection#7934180b0d111857371e0c001c17391f1d185711110a571e160f"><span class="__cf_email__" data-cfemail="602d01121408014e2e071519050e200604014e0808134e070f16">[email&#160;protected]</span></a>.

SUPPLEMENTARY INFORMATION: In the Federal Register of Thursday, May 7, 
2026 (91 FR 24879), appearing on page 24879 in FR Doc. 2026-09012, the 
following correction is made:
    On page 24879, in the table, the entry for ANDA 210285 is removed.

Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-20460 Filed 10-5-26; 8:45 am]
BILLING CODE 4164-01-P


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