reference listed drug


Also found in: Acronyms.

reference listed drug

An approved drug product to which new generic versions are compared to show bioequivalence. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application.

By designating a single reference-listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand-name counterpart.
Segen's Medical Dictionary. © 2012 Farlex, Inc. All rights reserved.
References in periodicals archive ?
(147) Under that previous mechanism, an ANDA applicant proposed a generic product with labeling that differs from that of the reference listed drug, and the applicant argued to the FDA that the proposed labeling rendered the drug as safe and effective as the concurrently approved labeling of the listed drug.
The company said Tadalafil Tablets USP is the first generic version of the reference listed drug Adcirca from Eli Lilly and Company.
A substantially complete ANDA, as defined in 21 CFR 314.101(b)(1), is "an ANDA that on its face is sufficiently complete to permit a substantive review." (4) The RTR Guidance goes on to state," In FY 2015, the five most frequent bases for an RTR determination were (in order of frequency): inadequate stability data; incomplete information request response; inadequate dissolution; drug product was not qualitatively and quantitatively (Q1/Q2 same) the same as the reference listed drug (RLD); and failure to respond to information request within the prescribed timeframe."
NEW YORK -- Amneal Pharmaceuticals LLC has launched its ABrated generic for Lutera 28 (levonorgestrel and ethinyl estradiol tablets, USP), 0.1 mg/0.02 mg, the reference listed drug for the former Alesse brand.
sales of Methylphenidate Hydrochloride ER tablets were approximately $1.4B for the 12 months ended February 2019, according to IQVIA, although actual generic market values are expected to be lower." As previously announced, Lannett's strategic alliance partner, Andor Pharmaceuticals, recently received approval from the FDA of its Abbreviated New Drug Application of Methylphenidate Hydrochloride ER tablets USP in 18 mg, 27 mg, 36 mg and 54 mg strengths, the therapeutic equivalent to the reference listed drug, Concerta Extended-Release Tablets, 18 mg, 27 mg, 36 mg and 54 mg, of Janssen Pharmaceuticals (JNJ).
The company said the Levofloxacin Oral Solution USP in 25 mg/ml is the therapeutic equivalent to the reference listed drug, Levaquin Oral Solution in 25 mg/ml of Janssen Pharmaceuticals Inc.
The approved ANDA is bioequivalent and therapeutically equivalent to the reference listed drug product Tricor (Abbvie Inc.).
What are the differences in the container closure system(s) between this product and the Reference Listed Drug (RLD)?
The company said the Abbreviated New Drug Application (ANDA) for Dronabinol Capsules USP, 2.5 mg, 5 mg and 10 mg is the therapeutic equivalent to the reference listed drug, Marinol Capsules 2.5 mg, 5 mg and 10 mg from AbbVie Inc.
Besides the prioritization of ANDAs for sole-source products, the regulatory agency has already prioritized potential first generic products for which there are no blocking patents or exclusivities on the reference listed drug; ANDAs related to drug shortages; ANDA submissions subject to special review programs; ANDAs related to public health emergencies; submissions related to certain government purchasing or procurement activities; submissions subject to statutory mandates or other legal requirements; and supplements for which expedited reviews are requested.
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