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Quantum Pharmics ANDA withdrawals

Executive Summary

AHP subsidiary formally notified of FDA withdrawal of 25 ANDAs via a June 19 Federal Register notice. The notice follows up on a Nov. 17 agency letter to the company informing them that the withdrawals were being initiated based on concerns raised about application data reliability and product bioinequivalence ("The Pink Sheet" Nov. 20, p. 11).
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PS017668

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