Abbreviated New Drug Application (ANDA)
What is ANDA?
ANDA stands for Abbreviated New Drug Application. It is submitted to U.S. Food and Drug Administration (FDA) for approval of a generic version of an existing brand-name drug that is no longer protected by a patent or exclusivity. ANDA demonstrates that the proposed generic drug is bioequivalent to the reference (brand-name) drug in terms of dosage form, strength, route of administration, quality, performance characteristics, and labelling. Approval of an ANDA allows the generic drug to be marketed and sold as a therapeutically equivalent substitute for the brand-name drug.
How does ANDA help in pharma?
Abbreviated New Drug Application (ANDA) is a written request for the review and approval of a generic drug product. It is submitted to the US Food and Drug Administration (FDA). The goal of the ANDA process is to provide a streamlined, cost-effective pathway to market for generic drugs. This enhances medication accessibility and affordability for consumers. Once approved, the manufacturer can market the generic drug as a safe, effective, and lower-cost alternative to the brand-name drug. The ANDA process is an essential part of the regulatory framework for generic drug approval in the US.