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

6 October 2026

In plain English

FDA issues a correction to its May 7, 2026 notice withdrawing approval of 15 ANDAs effective June 8, 2026, including corrections to ANDA 210285 for dimethyl fumarate delayed-release capsules.

Read the official notice
Topic
Product safety
Regulator
FDA
Published
6 October 2026
For
Imports
Where it applies
United States
Source
FDA (Food and Drug Administration)

From the notice

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document announced the withdrawal of approval of 15 abbreviated new drug applications (ANDAs) from multiple applicants, withdrawn as of June 8, 2026.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., 670
The full text is at the source

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