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GENERIC TOPICAL CORTICOSTEROID BIOEQUIVALENCE GUIDELINES

Executive Summary

GENERIC TOPICAL CORTICOSTEROID BIOEQUIVALENCE GUIDELINES will be discussed at a March 27 meeting hosted by FDA's Office of Generic Drugs and Office of Small Business, Scientific and Trade Affairs. FDA said it plans to discuss three approaches to corticosteroid topical equivalence: the Stoughton assay, which is the current standard; a dermatopharmacokinetic assay; and in vitro dissolution testing. The meeting was announced in the Feb. 25 Federal Register and will be held at FDA's Parklawn Building, conference room D, beginning at 9 a.m. The meeting will be the first step in developing new standards for generic corticosteroid bioequivalence testing, FDA said. The agency anticipates that there probably will be more agency/industry discussions and the Office of Generic Drugs also expects to bring the issue before a future meeting of the Generic Drugs Advisory Committee. The Office of Generic Drugs has been approving generic topical corticosteroids based on studies using a vasoconstrictor assay developed by Richard Stoughton, MD. A July 1987 guideline established the Stoughton assay as the standard for bioequivalance of the products. The agency has been studying how to improve the guideline for several years. In April 1990, FDA said it was close to issuing an interim study guidance that would have changed the methods for using the assay ("The Pink Sheet" April 16, 1990, T&G-10). That interim guidance was never issued. The new Office of Generic Drugs Director Roger Williams, MD, has stressed in several public appearances the need for better understanding of topical bioequivalence issues. The agency has not held up ANDA approvals for topical corticosteroids, however; the most recent such approval was for NMC Laboratories' fluocinonide cream on Feb. 14 ("The Pink Sheet" Feb. 24, T&G-4). While one possible direction to be discussed at the March 27 meeting will be to modify and improve the Stoughton assay in order to make it a better discriminator of bioequivalence, FDA said, the agency plans to evaluate other approaches as well. The meeting will also include discussion of a possible dermatopharmacokinetic assay, which would involve collecting skin samples from beneath the area of corticosteroid application and measuring the amount of drug in the skin. A third possible component of a new guidance that will be discussed at the meeting is the use of in vitro dissolution testing to measure bioequivalence. If all three approaches are found to be valid, the agency may require future generic topical corticosteroids to meet all three, FDA said. The agency and industry may have to conduct some studies to evaluate the merits of the possible tests, the agency noted.
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