Pink Sheet is part 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

FDA Draws Regulatory Line Between Moxduo, HIV Combos

Executive Summary

HIV products often increase potency in combination, agency says.

You may also be interested in...



Deal Watch: Hep C M&A Still Thriving; Plus AstraZeneca/Synairgen, MorphoSys/Merck Serono, ViiV/J&J

Merck beats out bids from AbbVie and Johnson & Johnson for Idenix Pharmaceuticals, gaining possession of three promising HCV drug candidates.

FDA “Combination Rule” Trips Up QRxPharma’s Moxduo

Morphine/oxycodone fixed-dose product must offer efficacy or safety advantage over individual drug components because the two opioids are not generally used together to treat acute pain, agency says; QRxPharma fails to convince advisory committee that respiratory safety advantage exists.

QRxPharma Given Statistical Leeway With Moxduo, To No Avail

In search of evidence of a respiratory safety benefit with the two-opioid combination product, FDA agreed to consider exploratory and post hoc analyses from a safety study that failed its primary endpoint.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

PS056080

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