Exalgo, hydromorphone extended release tablet was approved March 1, 2010. I waited a couple of days to see if it was approved under 505(b)(1) or 505(b)(2). At this writing, we don’t know.
We have previously detailed in this blog the regulatory approval saga for this drug. When we last heard, FDA had told CombinatoRx/Covidien/Alza (clinical developer/commercialization/manufacturer & IP holder, respectively) that the NDA was deficient under 505(b)(1) but perhaps the sponsors should consider 505(b)(2). As we have stated before, hydromorphone has been on the market for decades, so a 505(b)(1) filing was puzzling. We’ll continue to follow this until we get a verdict.