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Re: genisi post# 179536

Thursday, 06/19/2014 5:29:33 PM

Thursday, June 19, 2014 5:29:33 PM

Post# of 257262
Correct! DRTX’s Dalvance has non-patent Orange Book exclusivity until May 23, 2024. Dalvance was approved by the FDA on 5/23/14; it received 5 years of NCE exclusivity and an additional 5 years of ‘GAIN’ exclusivity as a novel antibiotic—10 years of exclusivity in all.

More discussion:
http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2014/06/dalvance-gains-bonus-exclusivity-fda-grants-the-first-period-of-gain-act-exclusivity.html

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