Role of an RLD in an ANDA

Role of an RLD in an ANDA

A Reference Listed Drug (RLD) is an approved drug product to which the ANDA applicant must show its proposed generic drug is the same with respect to active ingredient(s), dosage form, route of administration, strength, labeling and conditions of use, among other characteristics. Also in evaluating drug product formulation and inactive ingredients ,an ANDA applicant must compare its proposed generic drug to the RLD’s formulation.

RLD play an important role in the generic drug development process.FDA requires many rigorous tests and procedures to assure that the generic drug can be substituted for the brand name drug. The FDA bases evaluations of substitutability, or “therapeutic equivalence” of generic drugs on scientific evaluations. By law a generic drug product must contain the identical amounts of the same active ingredient(s) as the brand name product. Drug products evaluated as “therapeutically equivalent” can be expected to have equal effect and no difference when substituted for the brand name product.