Department of Health and Human Services
Food and Drug Administration
- [Docket No. FDA-2026-N-4291]
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 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document announced the withdrawal of approval of 15 abbreviated new drug applications (ANDAs) from multiple applicants, withdrawn as of June 8, 2026.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Laboratories, LLC., U.S. Agent for Sawai USA, Inc., informed FDA that they did not want the approval of the ANDA withdrawn.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Upsher-Smith Laboratories, LLC., U.S. Agent for Sawai USA, Inc., timely requested that approval of the ANDA not be withdrawn, the approval is still in effect.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, Martha.Nguyen@fda.hhs.gov.