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Table 1.

Summary of food effects and labels of 23 NMEs that were approved by the FDA from January 2000 to May 2009

NameAUC ratio (fed/fasted)CV fastedCV fedCV fed-CV fastedLabel
Lapatinib 4.1 68% 52% −16% Fasted 
Posaconazole 3.6 36% 41% 5% Fed 
Erlotinib 2.09 36% 18% −18% Fasted 
Alfuzosin HCl 69% 40% −29% Fed 
Ziprasidone HCl 44% 22% −22% Fed 
Nitazoxanide 1.9 35% 37% 2% Fed 
Rifaximin 1.89 51% 26% −25% Either 
Nilotinib 1.74 35% 30% −5% Fasted 
Cinacalcet 1.68 60% 46% −14% Fed 
Deferasirox 1.62 36% 31% −5% Fasted 
Etravirine 1.54 111% 80% −31% Fed 
Vorinostat 1.38 43% 32% −11% Fed 
Rufinamide 1.34 30% 28% −2% Fed 
Gefitinib 1.33 55% 40% −15% Either 
Darunavir 1.3 15-35% 15-35% 0% Fed 
Tapentadol 1.26 36% 29% −7% Either 
Rasagiline 0.8 30% 32% 2% Either 
Voriconazole 0.76 125% 150% 25% Fasted 
Sorafenib 0.69 36% 53% 17% Fasted 
Sodium oxybate 0.65 38% 42% 4% Fasted 
Tegaserod maleate 0.42 26% 32% 6% Fasted 
Eltrombopag 0.41 28% 27% −1% Fasted 
Aliskiren 0.3 49% 60% 11% Fasted 
NameAUC ratio (fed/fasted)CV fastedCV fedCV fed-CV fastedLabel
Lapatinib 4.1 68% 52% −16% Fasted 
Posaconazole 3.6 36% 41% 5% Fed 
Erlotinib 2.09 36% 18% −18% Fasted 
Alfuzosin HCl 69% 40% −29% Fed 
Ziprasidone HCl 44% 22% −22% Fed 
Nitazoxanide 1.9 35% 37% 2% Fed 
Rifaximin 1.89 51% 26% −25% Either 
Nilotinib 1.74 35% 30% −5% Fasted 
Cinacalcet 1.68 60% 46% −14% Fed 
Deferasirox 1.62 36% 31% −5% Fasted 
Etravirine 1.54 111% 80% −31% Fed 
Vorinostat 1.38 43% 32% −11% Fed 
Rufinamide 1.34 30% 28% −2% Fed 
Gefitinib 1.33 55% 40% −15% Either 
Darunavir 1.3 15-35% 15-35% 0% Fed 
Tapentadol 1.26 36% 29% −7% Either 
Rasagiline 0.8 30% 32% 2% Either 
Voriconazole 0.76 125% 150% 25% Fasted 
Sorafenib 0.69 36% 53% 17% Fasted 
Sodium oxybate 0.65 38% 42% 4% Fasted 
Tegaserod maleate 0.42 26% 32% 6% Fasted 
Eltrombopag 0.41 28% 27% −1% Fasted 
Aliskiren 0.3 49% 60% 11% Fasted 

NOTE: NMEs with both AUC and CV data available were included.

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