2026-12044: Masuu Global Solutions LLC, U.S. Agent for Extrovis AG, et al.; Withdrawal of Approval of 11 Abbreviated New Drug Applications; Correction
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The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register on February 20, 2026. The document announced the withdrawal of approval of 11 abbreviated new drug applications (ANDAs) from multiple applicants, withdrawn as of March 23, 2026. The document indicated that FDA was withdrawing approval of ANDAs 078022 for propranolol hydrochloride (HCl), extended- release capsule, 60 milligrams (mg), 80 mg, 120 mg, and 160 mg, and 090665 for lidocaine HCl, injectable, 2%, held by Masuu Global Solutions LLC, U.S. Agent for Extrovis AG, 2255 Glades Rd., Suite 324A, Boca Raton, FL 33431. Before FDA withdrew the approval of these ANDAs, Masuu Global Solutions LLC, U.S. Agent for Extrovis AG, informed FDA that they did not want the approval of the ANDAs withdrawn. Because Masuu Global Solutions LLC, U.S. Agent for Extrovis AG, timely requested that approval of their ANDAs not be withdrawn, the approvals are still in effect. This notice corrects that error.
The agency’s own summary, as published.
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