$6-7.$ Spotlight on Pfizer, Inc.$-$Defenses to Product Liability. Prescription drugs in the United States must be approved by the Food and Drug Administration $($FDA$)$ before they can be sold. A drug maker whose product is approved through the FDA's "abbreviated new drug application" $($ANDA$)$ process cannot later change the label without FDA approval. Pfizer Inc. makes and sells by prescription Depo$-$T$,$ a testosterone replacement drug classified as an ANDA$-$approved drug. Rodney Guilbeau filed a claim in a federal district court against Pfizer, alleging that he had experienced a "cardiovascular event"

Critical Thinking and