Question

According to the FDA, which of the following is required to prove that a generic medication is equivalent to a brand name medication?

a) Animal testing
b) Clinical trials
c) Proof of safety only
d) Marketing approval

Answer 1

To prove a generic medication is equivalent to a brand name medication, an Abbreviated New Drug Application (ANDA) is submitted to the FDA, demonstrating bioequivalence through analytical and pharmacokinetic studies, not typically including clinical trials.

Step-by-step explanation:

According to the U.S. Food and Drug Administration (FDA), to prove that a generic medication is equivalent to a brand name medication, the manufacturer must submit an Abbreviated New Drug Application (ANDA). The ANDA demonstrates that the generic product is bioequivalent to the original drug, meaning it has the same dosage form, safety, strength, route of administration, quality, performance characteristics, and intended use. Clinical trials are not usually required for generics unless there is a specific concern about the drug. The evidence needed typically includes data on the bioequivalence of the product achieved through analytical and pharmacokinetic studies. This is different from new drugs, which require extensive clinical trials.