Federal Register: FDA Issues Notice TOVALT ODT Tablets, 5 Mg, 10 Mg Not Withdrawn From Sale for Safety or Effectiveness
July 09, 2026
July 09, 2026
WASHINGTON, July 9 (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(FDA) has determined that TOVALT ODT orally disintegrating tablets, 5 milligrams (mg) and 10 mg, were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for zolpidem tartrate . . .
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The Food and Drug Administration (FDA) has determined that TOVALT ODT orally disintegrating tablets, 5 milligrams (mg) and 10 mg, were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for zolpidem tartrate . . .