Consumer Investigative Release With Example In Orange
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FAQ
ANDA: Abbreviated new drug application; FDA: Food and Drug Administration; RLD: Reference listed drug; RS: Reference standard.
The coding system for therapeutic equivalence evaluations is designed to allow users to determine quickly whether the Agency has evaluated a particular approved prescription drug product (e.g., a particular strength of an approved drug that is not on the Discontinued Drug Product list) as therapeutically equivalent to ...
If there are approved generic products of another firm, the RLD will be "No" and all the products within the Dosage Form; Route grouping will have a Therapeutic Equivalence Code (TE Code). Products that have been discontinued are in the Discontinued section and do not have RLD or TE Codes.
Final answer: The first letter in the Orange Book rating code indicates the Therapeutic equivalence. An 'A' rating signifies that the drug is recognized as therapeutically equivalent by the FDA, while a 'B' rating suggests it is not.
The concept of therapeutic equivalence applies only to drug products containing the identical active ingredient(s) and does not encompass a comparison of different therapeutic agents used for the same condition (e.g., meperidine hydrochloride vs. morphine sulfate for the treatment of pain).
Reference Standard (RS) A “reference standard” is the drug product selected by FDA that an applicant seeking approval of an ANDA must use in conducting an in vivo bioequivalence study required for approval of an ANDA. In the electronic Orange Book, a reference standard is identified by “RS” in the RS column.
A “ZB” code is assigned to all nonprescription pharmaceuticals and legend pharmaceutical entities that have not been evaluated in the “Orange Book.” If one should encounter a “ZB” rating, do not dispense that particular pharmaceutical because no equivalence data is available.
Koblitz — Identification of and comparison to a Reference Listed Drug (“RLD”) and Reference Standards (“RS”) are the lynchpin of generic drug development and approval.
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