Sunday, November 8, 2009

On December 8, 2009 -- FDA Pediatric Advisory Committee To Address Vytorin/Zetia Safety


The FDA's website now bears a notice of recently-scheduled Advisory Committee meetings. On December 8, 2009, starting at 8 am, EST -- several drugs (in addition to the above two, which are still among Merck's billion dollar franchises -- but perhaps not for very much longer). Each drug will receive reviews mandated by the Best Pharmaceuticals for Children Act; by December we should know the outcome of ARBITER 6 - HALTS (the smallish niacin study, that most think holds only bad news for Zetia):

. . . .On December 8, 2009, the Pediatric Advisory Committee will meet to discuss pediatric-focused safety reviews. . . for. . . Zetia (ezetimibe), Vytorin (ezetimibe/simvastatin), Ventolin HFA (albuterol sulfate). The committee will also receive a brief update on atypical antipsychotic drugs as requested by the Pediatric Advisory Committee Meeting on November 18, 2008. . . .

I will post background materials, as they become available, in full-text, right here.

1 comment:

condor said...

Hey you, once at 8:42 am, on one of the earliest posts? Smile…