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2018-03-12 Withdrawal of Approval of NDA vs. NDA

Open grishagin opened this issue 6 years ago • 0 comments

Withdrawal of Approval of NDA, versus withdrawal of NDA for safety or efficacy reasons


Federal Register notices like https://www.gpo.gov/fdsys/pkg/FR-2006-06-16/html/E6-9440.htm
Specify when an NDA has been withdrawn --- when it has ended.
Ideally, this would be captured systematically.
This is especially important in the case of TOCAINIDE 27DXO59SAN
It is listed on a withdrawn (safety) list circa 1986, but the NDA file was updated by FDA as late as 2001. It appears to have been marketed until 2006.

grishagin avatar Mar 12 '18 19:03 grishagin