Federal Register #FDA-2026-P-4232

FDA Regulatory Determination on RASUVO (Methotrexate) Solution and Pathway for Generics

This notice from the Food and Drug Administration (FDA), under the Department of Health and Human Services, provides a regulatory determination regarding RASUVO (methotrexate) solution: - Government Buyer: - Department of Health and Human Services (HHS) - Food and Drug Administration (FDA) - OEM Highlight: - Medexus Pharma Inc. is the original manufacturer (OEM) of RASUVO (methotrexate) solution - Product Details: - RASUVO (methotrexate) solution, 27.5 mg/0.55 mL - NDA 205776 - Indicated for severe rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, and severe psoriasis in adults - Regulatory Determination: - FDA confirms RASUVO was not withdrawn from sale for safety or effectiveness reasons - Enables submission and potential approval of generic versions (ANDAs) referencing this product - Notable Requirements: - No procurement or purchase is being requested - No specific quantities, part numbers, or service requirements are listed - Notice is relevant for generic drug manufacturers seeking to enter the market for this product

Description

The Food and Drug Administration (FDA) has determined that RASUVO (methotrexate) solution, 27.5 mg/0.55 mL, was not withdrawn from sale for reasons of safety or effectiveness. This determination allows FDA to approve abbreviated new drug applications (ANDAs) for RASUVO if all other legal and regulatory requirements are met. RASUVO is indicated for management of severe rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, and severe psoriasis in adults. The drug is currently listed in the Discontinued Drug Product List section of the Orange Book but may be approved for generic versions as long as requirements are met.

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