FDA reviewer recommends blackbox warning for EMSAM

Posted by jrbecker on October 25, 2005, at 10:59:49

possibly sour news for EMSAM that might hurt its market launch....despite aggressive lobbying to prevent the need for a black-box warning on the drug's product label, members of the FDA panel have recommended just that....
http://yahoo.reuters.com/financeQuoteCompanyNewsArticle.jhtml?duid=mtfh75067_2005-10-25_13-48-49_wbt004085_newsml
This hearing will continue until tomorrow (26th), so the issue is not dead in the water. Also, there is a chance that Somerset might decide to launch the product anyways despite the scarlet letter of the black-box mandate.

Thread

FDA reviewer recommends blackbox warning for EMSAM jrbecker 10/25/05
Re: FDA reviewer recommends ....update 1 jrbecker 10/25/05
Re: FDA reviewer recommends ....update 1 med_empowered 10/25/05
Re: FDA reviewer recommends blackbox warning for EMSAM ed_uk 10/25/05
Re: FDA reviewer recommends blackbox warning for EMSAM cecilia 10/26/05
FDA PANEL states no need for blackbox warning jrbecker 10/26/05
FDA PANEL states no need for blackbox warning jrbecker 10/26/05
Re: FDA PANEL states no need for blackbox warning RobertDavid 10/26/05
Re: FDA PANEL states no need for blackbox warning Cecilia 10/27/05
Re: thanks jrbecker! (nm) ravenstorm 10/27/05
Re: FDA reviewer recommends blackbox warning for E Psyc 1 10/27/05
Re: FDA PANEL states no need for blackbox warning jclint 10/27/05

Post a new follow-up

Notify the administrators

Start a new thread

poster:jrbecker thread:571697
URL: http://www.dr-bob.org/babble/20051024/msgs/571697.html