Saturday, April 07, 2007

FDA Drugs: December 2006

2007: Mar | Feb | Jan . . . 2006: Dec | Nov | Oct | Sep

I'm a bit behind on listing relevant FDA update info, so I'll get you all up to date.
  • Zyprexa (olanzapine) labeling change: Label was revised to state that "Rare postmarketing reports of hepatitis have been received. Very rare cases of cholestatic or mixed liver injury have also been reported in the postmarketing period." [.pdf]
  • Bifeprunox for Schizophrenia: Phase III results were released showing that patients did better on this than on placebo over 6 months (not hard to beat placebo). They also reported weight and lipid profile reductions. Their New Drug Application was submitted to the FDA in October.
  • Invega (iloperidone) results: These results are interesting in that they looked at efficacy and side effects data stratified by whether or not one had a particular pharmacogenetic genotype. They do not identify the genotype, but I suspect it is something like DRD4 or DAT-1. So far, however, we have yet to see the promise of a pharmacogenetic test which one would perform prior to prescribing a drug. For this to really work, the test will have to be free and the results available promptly.
  • Melt-in-your-mouth Methadone: Roxane got a dissolvable 40mg methadone approved.
  • Invega (iloperidone) approved: This is an active metabolite of Risperdal/risperidone, very similar to this atypical antipsychotic. [label] [detailed review]