Pink Sheet is part of the Business Intelligence Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

Endpoint Selection Still An Issue For Publication-Based NDAs

Executive Summary

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.

Advertisement

Related Content

Economics Of Gaining Approval For Unapproved Phenylephrine Remains Question Mark
Phenylephrine, Long Time On Market For Hypotension, Goes To FDA Panel

Topics

Related Companies

Advertisement
UsernamePublicRestriction

Register

PS054755

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel