Question

The first letter in the Orange Book rating code indicates:

A) Dosage Form
B) Brand Name
C) Generic Equivalence
D) Therapeutic Category

Answer 1

The first letter in the Orange Book rating code refers to the Generic Equivalence of a drug, with 'A' denoting equivalence to a brand-name drug and 'B' indicating non-equivalence.

Step-by-step explanation:

The first letter in the Orange Book rating code indicates C) Generic Equivalence. The FDA's Orange Book provides information about drug products approved on the basis of safety and effectiveness by the FDA. This includes approval for generic drugs, which are required to be therapeutically equivalent to their brand-name counterparts. The rating code is a means of categorizing these drugs, with the first letter representing their equivalence to the brand-name reference listed drug.

A rating of 'A' indicates that a generic drug is considered to be therapeutically equivalent, while a rating of 'B' would mean the drug is not considered to be therapeutically equivalent.