Ding Dong is the Skinny Label (Effectively) Dead?
FDA Law Blog
SEPTEMBER 6, 2021
Instead, it was GSK who erred in omitting the post-MI language from the use code. Especially now with the utility of the use code minimized. Amarin even sued a health insurer alleging active encouragement to use Hikma’s generic version instead of Vascepa for the patented indication. But what is a “true carve-out?”
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