Many excellent drugs have passed all the necessary clinical trials, and they are approved in their original countries but still not approved by FDA!! Why??
I can mention Phenobarbital which is considered one of WHO Model List of Essential Medicines... Favipiravir already used in Japan; and natural drugs such as Diosmin "already sold under the brand name Daflon", cucrumin, thymoquinone, thymol etc.
I mean some synthetic drugs such as Phenobarbital and favipiravir; and natural drugs such as Diosmin "already sold under the brand name Daflon", cucrumin, thymoquinone etc.
I can't speak for other drugs listed above but for phenobarbital, the drug was before FDA began their review on safety and effectiveness. After that, it seems there were better medication options for seizure. However in 2022, Sezaby (phenobarbital sodium) is a barbiturate was approved by FDA indicated for the treatment of neonatal seizures
The answer is simple.
Different people ask different questions and are convinced their answer is the most appropriate for approval.
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