Determination That NAMENDA (Memantine Hydrochloride) Tablets, 5 Milligrams and 10 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness

e on its own initiative, whether a listed drug was withdrawn from sale for reasons of safety or effectiveness. This determination may be made at any time after the drug has been withdrawn from sale, but must be made prior to approving an ANDA that refers to the listed drug (Sec. 314.161 (21 CFR 314.161)). FDA may not approve an ANDA that does not refer to a listed drug. NAMENDA (memantine hydrochloride) tablets, 5 mg and 10 mg, are the subject of NDA 021487, held by AbbVie Inc., and initially approved on October 16, 2003. NAMENDA is indicated for the treatment of moderate to severe dementia of the Alzheimer's type. NAMENDA (memantine hydrochloride) tablets, 5 mg and 10 mg, are currently listed in the ``Discontinued Drug Product List'' section of the Orange Book. Newcastle Bioscience LLC submitted a citizen petition dated June 5, 2026 (Docket No. FDA-2026-P-6538), under 21 CFR 10.30, requesting that the Agency determine whether NAMENDA (memantine hydrochloride) tablets, 5 mg and 10 mg, were voluntarily withdrawn from sale for reasons of safety or effectiveness. After considering the citizen petition and reviewing Agency records and based on the information we have at this time, FDA has determined under Sec. 314.161 that NAMENDA (memantine hydrochloride) tablets, 5 mg and 10 mg, were not withdrawn for reasons of safety or effectiveness. The petitioner has identified no data or ot