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Economics Of Gaining Approval For Unapproved Phenylephrine Remains Question Mark

Executive Summary

West-Ward could be the first to gain approval for phenylephrine in hypotension, but the drug’s widespread use as a stand-by medication during surgery could deter FDA enforcement against unapproved versions.

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Endpoint Selection Still An Issue For Publication-Based NDAs

FDA’s Cardiovascular and Renal Drugs Advisory Committee Sept. 13 indicated approval for currently marketed phenylephrine to treat hypotension in the peri-operative setting based on the ability to increase blood pressure, but voted 8-2 against its use in shock because of the need for outcomes data.

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