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. Like all generics, FDA assigned Teva’s carvedilol an AB-rating, meaning that the products are therapeutically equivalent as labeled.
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