Final answer:
Pharmaceutical equivalents are considered by the FDA to be therapeutically equivalent to branded drugs. They undergo the ANDA process before approval to ensure their safety and efficacy, despite some historical regulatory challenges.
Step-by-step explanation:
Pharmaceutical equivalents are presumed by the FDA to be therapeutically equivalent to their name-brand counterparts. Generic drugs must undergo an Abbreviated New Drug Application (ANDA) process to demonstrate that they are interchangeable with the original branded drug in terms of dosage form, safety, strength, route of administration, quality, performance characteristics, and intended use. Despite generic drugs being less expensive, a major scandal in the 1980s involving the FDA's approval process for generic drugs raised issues of corruption and data falsification which led to several drugs being suspended or recalled.
Pharmaceutical equivalents are presumed by the FDA to be therapeutically equivalent. This means that they have the same active ingredient, strength, dosage form, and route of administration as the brand-name drug. In other words, they are expected to have the same therapeutic effect in patients.