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Showing posts from August, 2018

The FDA has approved an old recreational drug where an unwelcome side-effect is now the indication!

Orange Book Insights #1
Welcome to the inaugural posting of Orange Book Insights. This will hopefully be the first of many.
Not long ago I saw a headline in my local newspaper about the first approval of a cannabis-derived drug. No, this posting is not about that approval. My point is that the cannabis-related approval was considered significant enough to warrant an FDA press release and a newspaper headline.
No, this posting is about an equally well known recreational drug whose approval in December 2017 garnered, as far as I can tell, very little (if any) publicity. There was no press release from the FDA and no separate statement from the Commissioner, as there was for the cannabis-derived drug. No, this posting is about the FDA’s approval, on December 14, 2017, of (drum roll, please . . .) COCAINE!
Yes, cocaine is now an FDA approved drug (GOPRELTO (cocaine hydrochloride, 4% solution) from Genus Life Sciences Inc.). My discovery of GOPRELTO was completely fortuitous. I was lookin…