FDA Confirms Namenda Pills Not Yanked for Safety Flaws, Generics Live
Published Date: 9/1/2026
Notice
Summary
The Food and Drug Administration (FDA, Agency, or we) has determined that NAMENDA (memantine hydrochloride) tablets, 5 milligrams (mg) and 10 mg, were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to these drug products, and it will allow FDA to continue to approve ANDAs that refer to the products as long as the ANDAs meet relevant legal and regulatory requirements.
Analyzed Economic Effects
1 provisions identified: 1 benefits, 0 costs, 0 mixed.
FDA Keeps Generic Path Open for NAMENDA
The FDA found that NAMENDA (memantine hydrochloride) tablets, 5 mg and 10 mg, were not withdrawn from sale for reasons of safety or effectiveness. Because of that finding, FDA will not start procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to these products and will continue to approve ANDAs that refer to them so long as the ANDAs meet legal and regulatory requirements.
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