A Reference Listed Drug (RLD), as goes by its innate meaning, is an FDA approved drug product which can be referred to by a generic drug manufacturer while filing an Abbreviated New Drug Application (ANDA). An RLD is basically useful to establish bioequivalence of the product with that of an already approved one.
When a generical manufacturer is filing an ANDA, they should refer to the FDA designated RLD in the application portraying that the proposed generic drug is the same with respect to the active ingredient(s), dosage form, route of administration, strength, labeling, and conditions of use, along with other characteristics.
What if a designated RLD product no longer exists?
Generally, an innovative product or brand name product is designated as an RLD. But with the time, when generic products enter the market the brand name products eventually fade out creating a vacuum of RLD. At times, it is said that FDA designates one of the ANDA holders, who is the market leader in a given situation, as a new RLD.
In such scenarios, the most discussed is about who should be responsible for the revision of the labels, brand manufacturers or generic manufacturers. Once an ANDA holder is designated as RLD what kind of responsibilities are imposed on the ANDA RLD holder and who will be permitted to revise the labels when required. Get answers to all your queries about an RLD. Reach out to one of our Regulatory experts at firstname.lastname@example.org.