Elite Pharmaceuticals Inc (ELTP): sorry, 505 (b)2s are NOT generics I w...

rrr2003

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rrr2003

Re: dr_lowenstein post# 290531

Sunday, 06/03/2018 3:44:33 PM

Sunday, June 03, 2018 3:44:33 PM

sorry, 505 (b)2s are NOT generics

I would absolutely disagree. 505(b)(2) FDA applications can include branded generics.

https://camargopharma.com/what-is-505b2/

Potential types of 505(b)(2)s include:

Branded generics
DESI drugs
Prodrugs
Orphan drugs
Drug-device combinations

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