Federal Register #Docket No. FDA-2026-P-1636

FDA Notice on Regulatory Status of TOVALT ODT (Zolpidem Tartrate) Orally Disintegrating Tablets

This notice from the Food and Drug Administration (FDA) 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: - Biovail Laboratories International SRL (original manufacturer) - Valeant Pharmaceuticals North America, LLC (previous withdrawal requestor) - LGM Pharma Solutions, LLC (petitioner) - Products/Services: - TOVALT ODT (zolpidem tartrate) orally disintegrating tablets - Strengths: 5 mg and 10 mg - Notable Requirements: - FDA confirms these products were not withdrawn for safety or effectiveness reasons - Products remain listed in the Orange Book's Discontinued Drug Product List - Approval of generic versions (ANDAs) is permitted if all legal and regulatory requirements are met - No procurement or purchase of products or services is being solicited 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(FDA) has determined that TOVALT ODT (zolpidem tartrate) orally disintegrating tablets, 5 mg and 10 mg, were not withdrawn from sale for reasons of safety or effectiveness.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 the regulatory status of these drug products, supporting their continued approval and sale.

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