FDA Releases Draft Guidance For Updating Generic Drug Labels

The U.S. Food and Drug Administration (FDA) recently released a draft guidance document with the goal of facilitating certain updates to abbreviated new drug application (ANDA) labels. In particular, the draft guidance addresses updates to ANDA labels where the product’s reference listed drug (RLD) was withdrawn for reasons other than safety or effectiveness, providing insight on the responsibilities of ANDA holders to update their drug labels and the processes for doing so.