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The manufacturer discontinued both formulations in 2008 for business reasons, and a 2013 Federal Register determination confirmed the withdrawal was not for reasons of safety or effectiveness

The treatment protocol involves multiple injections over time, as determined by healthcare providers based on individual patient needs

Therefore, it can be challenging to interpret the clinical significance of anal sphincter defects (ie, the extent to which a sphincter defect explains anal weakness)

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To learn more about the benefits, risks, & differences of compounded medication substitutes you may visit the FDA Drug Shortage List & FDA Compounding Substitutions Information Page

10.1016/j.ejphar.2003.08.013 11 Belosic HalleZ.VlainicJ.DrmicD.StrinicD.LueticK.SucicM.et al (2017)