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

Novartis Finally Wins Arcapta Approval, Having Lost Battle On Desired Dose

This article was originally published in The Pink Sheet Daily

Executive Summary

Bronchodilator is approved for COPD at a 75 mcg dose, compared to 150 mcg and 300 mcg in Europe. Label nods to quality-of-life data.
Advertisement

Related Content

GSK’s Anoro Ellipta Heads To FDA Panel With Higher Hopes For Higher Dose
COPD Market Snapshot: New Products, Limited Differentiation
Boehringer’s Olodaterol Will Have To Pass LABA Hurdles At January Advisory Committee
EU's CHMP Gives Green Light To Three New Products And A New Indication For Afinitor
Novartis Revises U.S. Regulatory Strategy For Key Respiratory Drug
NICE Stuns Merck With Demand For Additional Daxas Trial
COPD Drug Dose Selection May Face Greater Scrutiny In Arcapta’s Wake
Arcapta Quality Of Life Data For High Dose Cannot Overcome Efficacy Questions
Arcapta Quality Of Life Data For High Dose Cannot Overcome Efficacy Questions
Novartis Resubmits Onbrez To FDA; Touts Comparative Trial Against Spiriva

Topics

Advertisement
UsernamePublicRestriction

Register

PS072593

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