ANDA Or 505(B)(2): Choosing The Right Abbreviated Approval Pathway For Your Drug

By Kristi Miller, SVP, Regulatory Affairs

For developers seeking to obtain approval for previously approved drug products in the United States, the U.S. Food and Drug Administration (FDA) offers two abbreviated approval pathways — an abbreviated new drug application (ANDA) and a 505(b)(2) application. Both of these applications rely on the agency’s finding of safety and effectiveness for a listed drug, but the data needed to support an ANDA and 505(b)(2) may differ.