Erowid Oxymorphone Vault : Bits & Pieces

Oxymorphone

Bits & Pieces

by Erowid

The "Bits & Pieces" section is intended for random snippets of information which don't fit
easily elsewhere and/or which have been newly added, but not yet carefully categorized.

What's Old Is New Again
Oxymorphone was originally approved by the FDA in 1959. The newer immediate- and extended- release products (Opana) were approved by the FDA on June 22, 2006. Oxymorphone was considered an NME (new molecular entity) for the New Drug Application review at FDA, even though it has been available under the name Numorphan, as an injectable solution (currently still on the market), rectal suppository (uncertain if it is still on the market, FDA says no and most recent product insert from the manufacturer is from 2004), and oral tablet (discontinued, probably in the early 1970s). It is possible this drug was such an old product that it was grandfathered in for efficacy circa 1962, when efficacy data started to be required (in addition to safety data). Thus, since the FDA had (apparently?) never fully reviewed it for efficacy, it was "new" to the reviewers. (Thanks N.C.)