Final answer:
The FDA's Abbreviated New Drug Application (ANDA) is the resource used to determine if two drugs are generically equivalent. It assesses whether a generic drug is interchangeable with its brand-name counterpart. This is crucial for ensuring the safety and efficacy of generics on the market.
Step-by-step explanation:
The FDA resource used to determine if two drugs are generically equivalent is the Abbreviated New Drug Application (ANDA).
When a drug patent expires, other companies can produce the medication as a generic drug. These are considered chemical equivalents to the original and must prove therapeutic equivalence to gain FDA approval. The ANDA process requires scientific evidence that a generic is interchangeable with the brand-name drug. During this process, the FDA reviews data that shows the generic drug has the same active ingredient, route of administration, dosage form, strength, and intended use as the original drug.
The 1989 scandal revealed corruption in generic drug approval, leading to increased scrutiny in the ANDA process. Long testing and strict regulations ensure that generic drugs are safe and effective, but also present challenges such as higher costs and delayed access to new treatments for patients. Generic drugs account for a significant portion of prescriptions, underscoring the importance of their availability.