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METACLOPROMIDE IN ABBOTT's ADD-VANTAGE SYSTEM IS INAPPROPRIATE FOR ANDA

Executive Summary

METACLOPROMIDE IN ABBOTT's ADD-VANTAGE SYSTEM IS INAPPROPRIATE FOR ANDA approval because the fixed dose format of the pre-mix system does not correlate with the drug's labeling instructions, which recommend dosage based on each patient's weight, FDA said in an April 18 letter to Abbott. The agency said that clinical studies "are necessary to establish the safety and effectiveness of metoclopramide in the ADD-Vantage system." FDA's letter was in response to a September 23 petition from Abbott requesting permission to file an ANDA for metoclopramide HCl 10 mg/ml and 20 mg/ml in the ADD-Vantage system. In the recent letter, FDA said that its March 10 letter to Abbott, which said the proposed product was ANDA suitable, was "in error." Explaining why metoclopramide in the ADD-Vantage system is not appropriate for an ANDA, FDA said: "The pre-measured doses provided by the proposed products, when used in the proposed system, would not, and indeed could not, conform to the dosing requirements in the approved labeling [which] . . . requires dose determinations to be made on the basis of a patient's weight." The proposed products, FDA continued, "would provide a fixed dose, regardless of patient weight [and] the safety and effectiveness of such a fixed dose has not been investigated." FDA further explained that "the studies which established the safety and efficacy of a metoclopramide dose titrated to a patient's specific weight are clearly not applicable to fixed dose for other weights." Clinical studies with metoclopramide, FDA said, "show actual adverse drug reaction incidence correlates with the strength and duration of drug administration." For example, FDA said, "a patient who weighs less than the weight recommended to receive 100 mg of the drug can be expected to suffer an increased incidence of serious adverse reactions. Conversely, a patient who weighs more than the weight recommended to receive 100 mg of the drug may experience a subtherapeutic effect from the dose." FDA noted that the ADD-Vantage system would not be appropriate for any products requiring dosage determinations based on body weight or surface. "The concept of pre-measured single unit of use packaging in the ADD-Vantage system is not compatible with drug products for which the appropriate dose must be individually calculated on the basis of body weight or surface area," FDA said.
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