InvestorsHub Logo
Followers 0
Posts 83
Boards Moderated 0
Alias Born 11/25/2016

Re: None

Saturday, 04/08/2017 6:03:02 PM

Saturday, April 08, 2017 6:03:02 PM

Post# of 38634
Inspirion has submitted data about the ADP of its proposed IR oxycodone. The Committees will be asked to discuss if these data are sufficient to support labeling claims.

Committees wants labeling about potential risks from ADF excipients with injection

See April 5th tweets
https://mobile.twitter.com/fdaadcomm?lang=en

?#FDA? AdCom votes 19-0 2 OK Inspirion's ?#RoxyBond? (oxycodone immediate-release) w claims of abuse deterrence by nasal (19-1)& IV routes(16-4)

Overall i would say this is good news for Ipci ....ad com behavior as expected