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Outlook For Orange Book Update Not Too Rosy

 
• By Derrick Gingery

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.

FDA entrance sign 2016

Generic sponsors waiting for the US FDA to offer a clearer picture of marketed products will likely have to wait a bit longer. The agency has no set schedule for when the Orange Book will be updated with all the new information contained in the mandated one-time marketing status reports.

Sponsors had to submit an updated accounting of whether their products remained actively marketed or had been discontinued to make sure the Orange Book was up-to-date. But an FDA official...

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