Final answer:
An Abbreviated New Drug Application (ANDA) is the FDA's approval process for generic drugs, ensuring they are therapeutically equivalent and bioequivalent to brand-name drugs. The ANDA requires generics to meet high standards of quality and manufacturing. It has made about 80% of approved drugs available as generics, promoting accessibility and affordability.
Step-by-step explanation:
The Abbreviated New Drug Application (ANDA) is a process by which the U.S. Food and Drug Administration (FDA) approves a generic drug. The ANDA demonstrates that the generic drug is therapeutically equivalent to the brand-name drug whose patent has expired. This means the generic must have the same active ingredient, dosage form, strength, route of administration, and intended use. It must also be bioequivalent, indicating that it delivers the same medicinal effect without significant differences in rate and extent of absorption.
To be approved through an ANDA, a generic drug must comply with the same stringent standards of quality and manufacturing as the original innovator drug. Once approved via an ANDA, generic drugs typically offer a cost-effective alternative to brand-name medications. By 2012, about 80% of all drugs approved by the FDA were available as generics, emphasizing the importance of the ANDA process in healthcare.
The ANDA process was created to balance the need for innovation with the necessity of making medicine more affordable for consumers. In response to a past generic drug scandal, the FDA has increased surveillance and oversight to prevent corruption and ensure the integrity of the drug approval process.