Determination That VASOPRESSIN IN SODIUM CHLORIDE (vasopressin) 0.9%, Injection, 50 units/50 milliliters (1 unit/milliliters) Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
FDA determined that vasopressin injection 50 units/50 mL was not withdrawn from sale for safety or effectiveness reasons, allowing ANDA applicants to rely on the reference listed drug for approval.
Aforeworn detected this change in the Pharmaceutical Manufacturing (FDA/DEA) space on July 16, 2026 and published this briefing so affected operators are forewarned rather than caught off guard. It is rated Low urgency. Generic/ANDA manufacturers and compounding outsourcing facilities (503B) seeking to market vasopressin products. 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FDA confirmed that the drug product was not withdrawn for safety or effectiveness, preserving its status as a reference listed drug for ANDA submissions.
Who it affects
Generic/ANDA manufacturers and compounding outsourcing facilities (503B) seeking to market vasopressin products.
What you must do
No immediate action required; ANDA applicants can continue to rely on this product as a reference standard.
Deadline
None.
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