Federal Register #2026-08435

FDA Notice on Status of OZEMPIC (Semaglutide) Solution, 2 mg/1.5 mL

This notice from the Food and Drug Administration (FDA) provides an official determination regarding the status of OZEMPIC (semaglutide) solution, 2 mg/1.5 mL: - Government Buyer: - Food and Drug Administration (FDA), Department of Health and Human Services - OEM Highlight: - Novo Nordisk Inc. is the Original Equipment Manufacturer (OEM) of OZEMPIC - Product Details: - OZEMPIC (semaglutide) solution, 2 mg/1.5 mL - No specific part numbers or quantities are referenced, as this is not a procurement action - Key Determination: - FDA confirms OZEMPIC was not withdrawn from sale for safety or effectiveness reasons - FDA will continue to approve abbreviated new drug applications (ANDAs) referencing OZEMPIC, provided all legal and regulatory requirements are met - OZEMPIC remains listed in the Discontinued Drug Product List section of the Orange Book for reasons other than safety or effectiveness - Labeling may be revised to meet current standards if necessary - No procurement of products or services is being requested or awarded in this notice

Description

The Food and Drug Administration (FDA) has determined that OZEMPIC (semaglutide) solution, 2 mg/1.5 mL, was not withdrawn from sale for reasons of safety or effectiveness. This determination means FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to this drug product. It also allows FDA to continue approving ANDAs referring to this product as long as they meet legal and regulatory requirements. The notice confirms that OZEMPIC remains approved and is not withdrawn for safety or effectiveness reasons.

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