Custom formulation development requires 4-6 weeks for initial samples, with full-scale production beginning within 8-10 weeks depending on specification complexity
The agency continues to require the manufacturer, Eli Lilly, to conduct post-marketing studies, including the SURPASS-CVOT cardiovascular outcomes trial, which will provide extended safety data on over 12,500 patients
Hussain SP, Hofseth LJ, Harris CC
Results indicated that the type-2 diabetes, on semaglutide group exhibited more advanced disease progression, as reflected by a greater number of diabetes medication classes, a more comorbidities, and a higher cardiovascular medication burden (see Supplemental Information Section 4 for further information)
Newer vendors still need to prove consistency