FDA Aims to Improve Orange Book to Boost Generic Competition

The FDA is updating the Orange Book to make it more useful for generic drug developers, Commissioner Scott Gottlieb said.

As part of that effort, the agency released a new draft guidance that explains to holders of NDAs and ANDAs the information they’re required to submit for marketing status notifications.

“Having timely, accurate information about what drugs are being actively marketed helps provide transparency around circumstances where generic competition is lacking,” Gottlieb said. “It helps us also better understand circumstances where generic medicines are being approved, but not marketed so that we can better consider any policy reasons why this may be occurring.”