Federal Register: FDA Rules NAMENDA Was Not Withdrawn for Safety Concerns, Allowing Generic Entry
September 01, 2026
September 01, 2026
WASHINGTON, Sept. 1 (TNSFR) -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following action in the Federal Register.
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The Food and Drug Administration (FDA) has determined that NAMENDA tablets, 5 milligrams (mg) and 10 mg, were not withdrawn from sale for reasons of safety or effectiveness.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 r . . .
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The Food and Drug Administration (FDA) has determined that NAMENDA tablets, 5 milligrams (mg) and 10 mg, were not withdrawn from sale for reasons of safety or effectiveness.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 r . . .