Elite Pharmaceuticals Inc (ELTP)

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http://www.navigant.com/~/media/WWW/Site/Insights/Life%20Sciences/DI_LifeSciences505b2_TL.ashx

The 505(b)(2) pathway is a particularly attractive choice
for those innovators because it offers both a potential for market exclusivity, and allows the innovator to utilize safety and/or efficacy data from the old drug to support portions of the new application.

The Drug Price Competition and Patent Term Restoration Act of 1984, also known as the Hatch-Waxman Amendments, added two provisions to U.S. law permitting drug product sponsors to rely upon FDA’s previous findings of safety and/or efficacy when registering new products. Under the law, both innovative and generic products can be introduced into the market without sponsors duplicating earlier, relevant clinical studies.

Section 505(b)(2) expressly permits FDA to rely on data not developed by the applicant to be considered for the registration of drug products.