Opportunity
Federal Register #2026-12044
FDA Correction: Drug Application Approvals for Masuu Global Solutions LLC/Extrovis AG Remain Valid
Buyer
Food and Drug Administration
Posted
June 16, 2026
Identifier
2026-12044
This notice is a correction from the Food and Drug Administration (FDA) regarding the status of certain drug application approvals: - Government Buyer: - Department of Health and Human Services (HHS) - Food and Drug Administration (FDA) - OEMs and Vendors: - Masuu Global Solutions LLC (U.S. Agent for Extrovis AG) - Extrovis AG - Products/Applications Mentioned: - Propranolol Hydrochloride (HCl) Extended-Release Capsules (60 mg, 80 mg, 120 mg, 160 mg) - ANDA 078022 - Lidocaine HCl Injectable, 2% - ANDA 090665 - Notable Details: - The original FDA notice had announced the withdrawal of approval for these drug applications. - Masuu Global Solutions LLC, acting as U.S. Agent for Extrovis AG, requested that the withdrawal not occur, and the request was made in time. - The FDA confirms that the approvals for these two ANDAs remain in effect. - No procurement, solicitation, or award is associated with this notice; it is strictly a regulatory correction.
Description
The Food and Drug Administration (FDA) issued a correction notice regarding the withdrawal of approval of 11 abbreviated new drug applications (ANDAs) from multiple applicants. The original notice announced withdrawal effective March 23, 2026, including ANDAs 078022 and 090665 held by Masuu Global Solutions LLC, U.S. Agent for Extrovis AG. However, Masuu Global Solutions LLC timely requested that approval of their ANDAs not be withdrawn, so the approvals remain in effect. This correction notice clarifies that the approvals for these ANDAs are still valid.