Filed Pre-INDs Currently in Development

The 505(b)(2) Regulatory Approval Pathway

The 505(b)(2) pathway is a middle road between new drug approval (NDA) and abbreviated new drug approval (ANDA). This hybrid pathway provides an opportunity for companies to reformulate drugs without the immense regulatory burden that goes into submitting a successful NDA.

While pharmaceutical companies do benefit from the lowered cost and time to market for a 505(b)(2) drug, patients stand to gain the most. Companies who follow this pathway take proven substances and create novel dosage forms that are easier to take, bring shorter, simpler dosing regimens to patients who struggle with adherence, combine commonly paired medications for dual action, or provide new strengths that meet more therapeutic needs. The reason the FDA created 505(b)(2) is simple: it improves the treatment landscape for patients and their care providers.