What's a 505(b)(2)?
There are three approval pathways by which drugs may gain approval through the U.S. Food and Drug Administration (FDA). The 505(b)(2) new drug application (NDA) is one of the three and was created by the Hatch-Waxman Amendments of 1984, with 505(b)(2) referring to a specific section of the U.S. Federal Food, Drug, and Cosmetic Act.
The provisions of a 505(b)(2) provide manufacturers who have certain types of drugs with an opportunity to acquire FDA approval without performing all the work that’s required with a standard 505(b)(1) NDA.