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Barr's conjugated estrogens ANDA

Executive Summary

FDA Commissioner Young and other agency officials recently met with Sen. D'Amato (R-NY) to discuss Barr's ANDA application for conjugated estrogens. Reportedly, the senator asked whether Barr is being treated fairly in regard to the product's review and whether there has been any further action on the application. Pomona, New York-based Barr submitted blood level studies for the application in accordance with an FDA decision on bioequivalence requirements for generic forms of Ayerst's Premarin. FDA had earlier rejected Barr's urinary excretion-based ANDA for estrogens. In a recent letter to FDA, Sen. Hatch (R-Utah) also expressed interest in FDA's review of Barr's generic conjugated estrogens.

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