Federal Register #FDA-2026-P-1636

FDA Notice on TOVALT ODT (Zolpidem Tartrate) Regulatory Status – No Procurement Requested

This FDA notice addresses the regulatory status of TOVALT ODT (zolpidem tartrate) orally disintegrating tablets: - Government Buyer: - Food and Drug Administration (FDA), Department of Health and Human Services - OEMs and Vendors: - TOVALT ODT (originally under NDA 021412 by Biovail Laboratories International SRL) - Products/Services: - TOVALT ODT (zolpidem tartrate) orally disintegrating tablets, 5 mg and 10 mg - No specific quantities or part numbers provided - Notable Requirements: - FDA confirms these tablets were not withdrawn for safety or effectiveness reasons - Enables approval of generic ANDAs for zolpidem tartrate ODT in 5 mg and 10 mg strengths - Product remains listed in the Orange Book's Discontinued Drug Product List for reasons other than safety or effectiveness - No procurement or purchase is being requested in this notice

Description

The Food and Drug Administration (FDA) has determined that TOVALT ODT (zolpidem tartrate) orally disintegrating tablets, 5 mg and 10 mg, were not withdrawn from sale for reasons of safety or effectiveness. This determination allows FDA to approve abbreviated new drug applications (ANDAs) for these tablets if all other legal and regulatory requirements are met. The notice confirms that the drug products were not withdrawn for safety or efficacy reasons, enabling continued approval and marketing.

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