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Agency, or we) has determined that NAMENDA (memantine hydrochloride) tablets, 5 milligrams (mg) and 10 mg, were not withdrawn from sale for reasons of safety or effectiveness.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.
US Federal Register - FDA Notices · September 01, 2026
Determination That NAMENDA (Memantine Hydrochloride) Tablets, 5 Milligrams and 10 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
FDA determined NAMENDA tablets were not withdrawn for safety or effectiveness reasons, permitting continued ANDA approvals.
Published by US Federal Register - FDA Notices. HealthSignal links to the original document; the summary above is extracted from the source text.