505 (b)(2) Application

A 505(b)(2) application is a type of New Drug Application (NDA) in the United States of America that allows a sponsor to obtain U.S. Food and Drug Administration (FDA) approval for a drug by relying, at least in part, on data not developed by the applicant. This can include published literature, studies not conducted by or for the applicant, or even data from a previous NDA. The 505(b)(2) pathway is designed to facilitate the approval of new formulations, strengths, dosages, or routes of administration of existing drugs, or to gain approval for new indications for previously approved drugs.
505(b)(2) pathway can be used in any of the following cases:
1. New indication
2. For new combination drugs
3. For changes in dosage form, strength and /or route of administration

Key aspects of the 505(b)(2) pathway include:

The 505(b)(2) pathway thus offers a flexible and efficient regulatory route to bring improved or modified versions of existing drugs to market, faster and at a lower cost benefiting both pharmaceutical companies and patients.