Determination That RASUVO (Methotrexate) Solution, 27.5 Milligrams/0.55 Milliliter (27.5 Milligrams/0.55 Milliliter), Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
FDA determined that RASUVO (methotrexate) solution 27.5 mg/0.55 mL was not withdrawn from sale for safety or effectiveness reasons, meaning ANDA applicants can rely on it as a Reference Listed Drug (RLD). This maintains the regulatory pathway for generic versions.
Aforeworn detected this change in the Pharmaceutical Manufacturing (FDA/DEA) space on July 22, 2026 and published this briefing so affected operators are forewarned rather than caught off guard. It is rated Low urgency. Generic/ANDA manufacturers, branded drug makers should confirm how it applies to their specific situation before acting. There is a time constraint attached: None. Acting after that point can mean penalties, a lapsed licence, or lost eligibility — exactly the kind of surprise Aforeworn exists to prevent. Aforeworn monitors Pharmaceutical Manufacturing (FDA/DEA) continuously and turns every detected change into a plain-English briefing like this one, so you always know first. Forewarned is forearmed.
What changed
FDA confirmed RASUVO remains a suitable RLD for ANDA referencing; no withdrawal for safety/effectiveness.
Who it affects
Generic/ANDA manufacturers, branded drug makers
What you must do
No immediate action required; ANDA applicants can continue referencing RASUVO.
Deadline
None
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