Ding Dong is the Skinny Label (Effectively) Dead?
FDA Law Blog
SEPTEMBER 6, 2021
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. Teva received tentative approval in June 2003 and launched in 2007 after a blocking patent expired. Par also has filed similar litigation.
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