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Re: Dancing in the dark post# 262437

Sunday, 04/05/2020 2:15:50 PM

Sunday, April 05, 2020 2:15:50 PM

Post# of 427141
D-

Meanwhile it was not a direct reply I posted my view about the label "issue". Shortly:

ANDAs must include the proposed labelling that will accompany the generic drug—and that labelling must generally be substantially the same as the labelling that accompanies the brand-name drug.

It should be read … applicable as "per indication" not as a label entirely. (ergo: R-IT should not be included in ANDAs' label).

Best,
G

"There are some things money can't buy. … For these, there is AMRN."

Disclosure: I am long with this stock. I wrote this post myself, and it expresses my own opinions (IMHO). I am not receiving compensation for

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