Opportunity
Federal Register #FDA-2026-P-6538
FDA Regulatory Notice on NAMENDA (Memantine Hydrochloride) Tablets, 5 mg and 10 mg
Buyer
Food and Drug Administration
Posted
September 01, 2026
Identifier
FDA-2026-P-6538
This FDA notice addresses the regulatory status of NAMENDA (memantine hydrochloride) tablets, 5 mg and 10 mg, for Alzheimer's treatment. - Government Buyer: - Food and Drug Administration (FDA), Department of Health and Human Services - OEMs and Vendors: - AbbVie Inc. (original manufacturer, NDA holder) - Newcastle Bioscience LLC (petitioner) - Products/Services Requested: - NAMENDA (memantine hydrochloride) tablets, 5 mg and 10 mg - No specific procurement, purchase quantities, or part numbers provided - Unique/Notable Requirements: - FDA determined NAMENDA tablets were not withdrawn for safety or effectiveness reasons - Allows continued approval of generic drug applications referencing these products - NAMENDA is indicated for moderate to severe Alzheimer's dementia - No procurement or award is announced in this notice
Description
The Food and Drug Administration (FDA) has determined that NAMENDA (memantine hydrochloride) tablets, 5 mg and 10 mg, were not withdrawn from sale for reasons of safety or effectiveness. This determination means that the FDA will not withdraw approval of abbreviated new drug applications (ANDAs) referring to these products and will continue to approve ANDAs that meet legal and regulatory requirements. NAMENDA is indicated for the treatment of moderate to severe dementia of the Alzheimer's type. The FDA reviewed the citizen petition and agency records and found no information indicating withdrawal for safety or effectiveness reasons.