FDA Correction: Withdrawal of 72 ANDAs - Upsher-Smith Laboratories

FR: Food and Drug Administration

Published March 26th, 2026

Detected March 26th, 2026

Summary

The FDA issued a correction to a notice that incorrectly announced the withdrawal of approval for Upsher-Smith Laboratories' abbreviated new drug application (ANDA) 070631 for valproic acid capsules. The company had timely requested that the approval not be withdrawn, and this correction reinstates its validity.

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What changed

The Food and Drug Administration (FDA) has issued a correction to a prior notice published on September 24, 2025. The original notice incorrectly stated that the FDA was withdrawing approval for 72 abbreviated new drug applications (ANDAs), including ANDA 070631 held by Upsher-Smith Laboratories, LLC for valproic acid capsules. This correction clarifies that Upsher-Smith Laboratories, LLC did not request the withdrawal of their ANDA, and therefore, its approval remains in effect.

This is a minor correction to a previous regulatory action. Compliance officers should note that the withdrawal of ANDA 070631 has been reversed due to an administrative error. No immediate action is required from regulated entities beyond acknowledging this correction. The FDA's original notice and this correction do not impose new obligations or penalties.

Source document (simplified)

Notice

Elite Laboratories, Inc., et al.; Withdrawal of Approval of 72 Abbreviated New Drug Applications; Correction

A Notice by the Food and Drug Administration on 03/26/2026

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Public Inspection Published Document: 2026-05913 (91 FR 14703) Document Headings ###### Department of Health and Human Services

Food and Drug Administration

[FDA-2025-N-3346]

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 on September 24, 2025 (90 FR 183), appearing on page 45942 in FR Doc. 2025-18453. The document announced the withdrawal of approval of 72 abbreviated new drug applications (ANDAs) from multiple applicants, withdrawn as of October 23, 2025. The document indicated that FDA was withdrawing approval of the ANDA 070631 for valproic acid, capsule, 250 milligrams, held by Upsher-Smith Laboratories, LLC, 6701 Evenstad Dr., Maple Grove, MN 55369. Before FDA withdrew the approval of this ANDA, Upsher-Smith Laboratories, LLC, 6701 Evenstad Dr., Maple Grove, MN 55369, informed FDA that they did not want the approval of the ANDA withdrawn. Because Upsher-Smith Laboratories, LLC, timely requested that approval of the ANDA not be withdrawn, the approval is still in effect. This notice corrects this error.

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, Martha.Nguyen@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

In the Federal Register of Wednesday September 24, 2025 (90 FR 183), appearing on page 45942 in FR Doc. 2025-18453, the following correction is made:

On page 45943, in the table, the entry for ANDA 070631 is removed.

Grace R. Graham,

Deputy Commissioner for Policy, Legislation, and International Affairs.

[FR Doc. 2026-05913 Filed 3-25-26; 8:45 am]

BILLING CODE 4164-01-P

Published Document: 2026-05913 (91 FR 14703)