American Cyanamid Company v. Food and Drug Administration and Joseph A. Califano, Secretary of Health, Education and Welfare

SPOTTSWOOD W. ROBINSON, III, Circuit Judge:

On June 3, 1968, the Food and Drug Administration (FDA) approved a new animal drug application (NADA) for Proban, a drug in capsule form manufactured by American Cyanamid Company (Cyanamid) and designed for the control of fleas on dogs. 1 FDA authorized this NADA on a finding that Proban had been shown to be safe and effective for its intended use. 2 FDA attached a qualification to its endorsement of Proban, however, rendering it available only on order of a licensed veterinarian. 3

Subsequently, Cyanamid researchers conducted tests that in Cyanamid’s…