Keyword Analysis & Research: reference listed drug for generic drugs


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Frequently Asked Questions

What is a reference listed drug?

• A reference listed drug (RLD) is the specific listed drug on which the ANDA applicant relies in seeking approval of its ANDA, i.e., the approved drug product the proposed generic

What are reference listed drugs (RLDS)?

Reference listed drugs (RLDs) play an important role in the generic drug development process. These drugs are licensed and FDA listed, and are usually the originally produced drug that all generics, produced thereafter, have been compared to. In order for a generic drug to gain FDA approval, it will have to model the RLD in a number of ways;

Why are authorized generic drugs not listed in FDA’s approved drug products?

Because an authorized generic drug is marketed under the brand name drug’s New Drug Application (NDA), it is not listed in FDA’s Approved Drug Products With Therapeutic Equivalence Evaluations (the Orange Book). An authorized generic is considered to be therapeutically equivalent to its brand-name drug because it is the same drug.

Where can I find a list of authorized generics?

FDA publishes a list of reported authorized generics and updates that list quarterly. On September 27, 2007, the President signed into law the Food and Drug Administration Amendments Act (FDAAA) (Public Law 110-85). Among other things, FDAAA added new subsection (t) to section 505 of the Federal Food, Drug, and Cosmetic Act (the Act).


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