Elite Pharmaceuticals Inc (ELTP)

[Hike]

So it's NOT possible to prove efficacy via 505b2 pathway using published literature or FDA findings?

These industry experts assert otherwise.

http://www.camargopharma.com/Userfiles/Why-505b2-is-a-Whole-Different-Animal.pdf

A 505(b)(2) application, on the other hand, is one for which
one or more of the studies relied upon for approval has not
been conducted by or for the applicant. In these cases, an
applicant may rely on published literature or on the FDA’s
previous finding of safety and/or effectiveness for the drug.

Heck even the FDA itself says so!

http://www.fda.gov/downloads/Drugs/Guidances/ucm079345.pdf

Section 505(b)(2) permits approval of applications other than those for
duplicate products and permits reliance for such approvals on literature or on an Agency finding of safety and/or effectiveness for an approved drug product.