Outlook For Orange Book Update Not Too Rosy
With about 20,000 products eligible for US marketing status report on drugs in Orange Book, there is no timeline for all changes to be made.
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180-day exclusivity would begin when a second ANDA is approvable, rather than at first-generic's launch, a potentially major change to the Hatch-Waxman framework if implemented.
US FDA could move sponsor's products from active to discontinued section of Orange Book if agency doesn't receive the FDARA-required report by Valentine's Day.
FDA says there are only a few situations where the ANDA status call to the project manager is necessary, and industry seems to agree that review system improvements make the once-contentious check-in process less necessary.