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Re: anfla post# 302825

Saturday, 10/03/2020 12:37:49 PM

Saturday, October 03, 2020 12:37:49 PM

Post# of 426183
Pulled this up. Delisting of patents.

April 2011, FDA sent Teva a letter in response to the de-listing of certain GSK patents from the Orange Book, instructing Teva to “revise [its] label to include the information associated with the [de-listed] patent.” As a result, Teva amended its label in 2011 to be an essential copy of GSK’s full label, meaning it covered all three indications: hypertension, CHF, and post-MI LVD. 
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