FDA’s New MAPP Shows the Route to Changing Ownership of Generic Drug Applications

The U.S. Food & Drug Administration (FDA) recently issued a new Manual of Policies and Procedures (MAPP), in which it explains the Office of Generic Drugs’ (OGD) policy on facilitating changes to generic drug applications and updating the Orange Book to reflect those changes.

MAPP 5242.1 makes clear that the policies, processes and procedures for changing ownership of an application differ based on whether the change is effected by a simple transfer of ownership or whether it results from a corporate merger or acquisition.

To read the full text of this Duane Morris Alert, please visit the firm website.