Rhodia, Inc., Hess & Clark Division v. Food and Drug Administration

LEVENTHAL, Circuit Judge:

Rhodia, Inc., Hess & Clark Division (Rho-dia) sought to amend approved new animal drug applications (NADA’s) in effect for three products containing the active drug furazolidone so as to include new sources of supply of the bulk drug in addition to the one named in the original NADA’s. The Director of the Bureau of Veterinary Medicine of the Food and Drug Administration (FDA) denied approval of Rhodia’s supplemental NADA’s. Finding the action arbitrary and capricious, we set aside the FDA order and remand for further proceedings.

I. BACKGROUND

Rhodia currently holds…