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 fortuito...