When filing for a drug product approval via the 505(b)(2) regulatory pathway rather than a traditional development pathway, companies are afforded several advantages. The pathway — which was established, along with the 505(j), by the 1984 Hatch-Waxman Amendments of the Federal FD&C Act (the addition of the Drug Price Competition and Patent Term Restoration sections) — offers companies a streamlined route for drug approval.

The 505(b)(2) pathway is a New Drug Application (NDA); however, unlike the traditional route of regulatory approval through the 505(b)(1), companies can submit existing safety and efficacy data of listed drugs in their reports to accelerate their submission and approval process.