Ding Dong is the Skinny Label (Effectively) Dead?
FDA Law Blog
SEPTEMBER 6, 2021
Teva received tentative approval in June 2003 and launched in 2007 after a blocking patent expired. Instead, it was GSK who erred in omitting the post-MI language from the use code. Amarin even sued a health insurer alleging active encouragement to use Hikma’s generic version instead of Vascepa for the patented indication.
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