View Single Post
 
Old Dec 31, 2005, 06:26 PM
Larry_Hoover's Avatar
Larry_Hoover Larry_Hoover is offline
Veteran Member
 
Member Since: Sep 2004
Location: Ontario
Posts: 471
Reports about supplemental applications will show up in the business section of the newspaper (higher stockholder value), or trade mags, or as brief communications in psych journals....They're just trying to hype the drug.

You haven't seen this new use referred to at the official website because it's not approved yet. Before AstraZeneca can change the wording of the drug monograph and patient information sheet to show the new indication, the FDA must approve the supplemental application, and any proposed wording changes in those documents. In short, your newsletter site will be the last place this news will show up.

Until then, of course, any doctor is still free to prescribe the drug "off-label" for bipolar depression. If and when the supplemental is approved, it will be a labelled use.

Lar