2 ms·
jump through FDA hoops Not that again. Bioequivalence is important so that a patient can take Levothyroxin 75 μg from Ranbaxy one month and Levothyroxin 75 μg
by HarryHirsch 7y ago
jump through FDA hoops
Not that again. Bioequivalence is important so that a patient can take Levothyroxin 75 μg from Ranbaxy one month and Levothyroxin 75 μg from Teva next month and notice no difference. Unfortunately, the market for orphan drugs is so small that it's impossible to recover the outlays.
- refurb 7y agoJust as an aside, once you start on a thyroid medication, it’s recommended you stick with that manufacturer. Yes, they are bioequivalent, but to the FDA that means 80%-125% of the originator. But yes, these markets where formally cheap drugs get 100x price increases are tiny markets where the outlay to get FDA approval is more than they’d make on it.