Ding Dong is the Skinny Label (Effectively) Dead?
FDA Law Blog
SEPTEMBER 6, 2021
Though the carve-out seems at odds with FDA’s regulations requiring generic drugs to have the “same labeling” as their RLDs, such regulations specifically provide for differences arising from carved-out, patent-protected method of use. Instead, it was GSK who erred in omitting the post-MI language from the use code.
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