Thursday, April 04, 2024 10:44:42 AM
Dave, if gV is considered bioequivalent, I'm not sure how that would ever be the case.
However, one interesting thing to note, is that BP's, from time-to-time, will send letters to medical practices, reminding them about prescribing generic products for off-label indications when there is a branded, patented product covering said indication. I'm not sure if Amarin has ever done this. I assume not. But it seems like something they SHOULD do. I recall seeing a letter sent by Pfizer like this for one of their drugs. I found it online. I should try to dig that up.
However, one interesting thing to note, is that BP's, from time-to-time, will send letters to medical practices, reminding them about prescribing generic products for off-label indications when there is a branded, patented product covering said indication. I'm not sure if Amarin has ever done this. I assume not. But it seems like something they SHOULD do. I recall seeing a letter sent by Pfizer like this for one of their drugs. I found it online. I should try to dig that up.
JRoon,
Suppose Hikma had the correct indication on the Label, Trigs only, and a doctor prescibed generic V to a CVD patient.
If the patient then had a heart attack, wouldn't the doctor be liable for malpractice? Would this fear keep the docs precribing V?
Dave
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