Ding Dong is the Skinny Label (Effectively) Dead?
FDA Law Blog
SEPTEMBER 6, 2021
Teva case, that the statutory provisions governing patent infringement, specifically induced infringement, do not address carve-outs. Teva submitted an ANDA in 2002, and after some complicated regulatory history, ultimately carved-out the congestive heart failure indication by way of a section viii statement.
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