FDA Correction: Upsher-Smith Laboratories' Valproic Acid ANDA 070631 Approval Remains Valid
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The FDA is issuing a correction to a Federal Register notice originally published on September 24, 2025 (90 FR 183, page 45942, FR Doc. 2025-18453), which announced the withdrawal of approval for 72 Abbreviated New Drug Applications (ANDAs) from multiple applicants, effective October 23, 2025. The original notice erroneously included ANDA 070631 — a valproic acid capsule (250 mg) held by Upsher-Smith Laboratories, LLC, located at 6701 Evenstad Dr., Maple Grove, MN 55369 — in the list of withdrawn approvals. Prior to the withdrawal taking effect, Upsher-Smith Laboratories timely notified the FDA that they did not consent to the withdrawal of their ANDA. Under FDA regulations, a timely objection from the applicant prevents the withdrawal from proceeding. As a result, the approval of ANDA 070631 remains in full effect and was never validly withdrawn. This correction notice serves to formally clarify the public record and ensure that the continued approval of this valproic acid product is accurately reflected in official FDA documentation.
AI-generated summary. May contain errors. Refer to official sources for legal decisions.
Key Changes
- ANDA 070631 (valproic acid capsule, 250 mg) held by Upsher-Smith Laboratories, LLC is formally reinstated — it was incorrectly listed as withdrawn in the September 24, 2025 Federal Register notice
- Original bulk withdrawal effective date was October 23, 2025; Upsher-Smith's ANDA is exempt due to timely objection filed before that date
- 71 of the original 72 ANDA withdrawals announced in FR Doc. 2025-18453 remain valid and in effect; only ANDA 070631 is corrected
+ 2 more changes with Pro
Obligations
What this law requires
Upsher-Smith Laboratories, LLC must maintain continuous compliance with all conditions of ANDA 070631 approval for valproic acid capsule (250 mg) as the approval remains in full effect
Upsher-Smith Laboratories, LLC must continue to comply with all applicable FDA regulations and requirements for manufacturing, labeling, and distribution of the valproic acid product under ANDA 070631
FDA must update and maintain accurate official documentation reflecting that ANDA 070631 approval for Upsher-Smith Laboratories' valproic acid capsule (250 mg) remains valid and was not withdrawn