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Barr ANDAs

Executive Summary

Barr ANDAs: The company met with FDA on Sept. 7 to discuss delays in approvals for five ANDAs. Barr said it has received approval on the biostudies of some of the ANDAs; however, final approval has been stalled at the agency. FDA blamed the delay on a general slowdown in approvals due to the generics investigation. However, according to the company, one ANDA had been delayed six weeks because the FDA employee assigned to the application refused to review a Barr ANDA. Among the ANDAs discussed at the meeting were conjugated estrogens and an erythromycin formulation. Barr submitted blood level studies for the conjugated estrogens in accordance with an FDA decision on bioequivalence requirements for generic forms of Ayerst's Premarin. Reportedly, FDA has asked Barr to submit new biostudies for the erythromycin ANDA. Barr has applications pending for two lower strengths of its erythromycin 500 mg enteric coated tabs approved in November 1988.
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PS016238

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