Elite Pharmaceuticals Inc (ELTP)

[Hike]

True. But who said Elite wasn't providing efficacy data?
They will as part of the 505(b)(2) process.

See:
http://www.dddmag.com/articles/2012/08/taking-505b2-route

Drugs approved under 505(b)(2), on the other hand, can rely in part on data from existing reference drugs. This means they can be developed and achieve FDA approval in as little as 30 months with only a fraction of the number of required clinical trials and at much lower cost. Additionally, unlike generic drugs approved under Section 505(j), where exclusivity can be held for only 180 days, the 505(b)(2) applicant may qualify for three, five, or seven years of market exclusivity, depending on the extent of the change to the previously approved drug and the type of clinical data included in the New Drug Application (NDA).

Regardless of the regulatory pathway one chooses for approval of an NDA, the FDA standards for the demonstration of efficacy and safety are the same; it is only the source of information that differs between the two paths. It is important to understand what constitutes sufficient evidence—and therefore which specific studies can be replaced by existing data for individual compounds.