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BioChica

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BioChica

Re: Pittkid post# 258782

Tuesday, 03/31/2020 10:13:24 AM

Tuesday, March 31, 2020 10:13:24 AM

Post# of 427139
One day it will be OTC, years away. The generics will have a tough time with there vision of off label prescriptions. They have not even filed an ANDA with FDA yet. The FDA continues to struggle to catch up on ANDA approvals. Average time to approve: Three years. Three long years.

They have to make sure their bioequivelant drug can perform the same as Vascepa.

Here is a the FDA process.

ANDA Filing
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