Phenylephrine, Long Time On Market For Hypotension, Goes To FDA Panel
This article was originally published in The Pink Sheet Daily
The agency seeks counsel on whether elevation in blood pressure is sufficient clinical benefit to approve the literature-based NDA for West-Ward Pharmaceutical’s product, which is currently an unapproved drug.
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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.
Industry also seems supportive of the idea, while Pew touts the power of the power of track-and-trace as a deterrent.