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Business · 22/04/2015

FDA Clears Oxytocin Drug Products for Approval

The US Food and Drug Administration (FDA) has determined that oxytocin drug products, including those containing 5%, 10%, and 20 USP Units per 500 and 1000 milliliter vials, were not withdrawn from sale due to safety or effectiveness concerns, paving the way for an abbreviated new drug application (ANDA) approval.

Original source language: Federal Register — Food and Drug AdministrationOpen original release →

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