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

Mylan Would Launch Nebivolol For Hypertension If Heart Failure Indication Is Delayed

This article was originally published in The Pink Sheet Daily

Executive Summary

Timeline could hinge on FDA’s acceptance of heart failure data from the SENIORS trial; nebivolol is currently “approvable” for hypertension.

You may also be interested in...



Mylan Finds Its Way Out Of The Woods: Forest Signs Nebivolol Licensing Agreement

Forest will assume development, sales and marketing rights for Mylan's beta blocker.

Mylan Finds Its Way Out Of The Woods: Forest Signs Nebivolol Licensing Agreement

Forest will assume development, sales and marketing rights for Mylan's beta blocker.

Mylan's Nebivolol Is "Approvable" At FDA

The beta blocker's user fee date had been extended by three months following submission of additional analysis. Mylan expects the anti-hypertensive to be the cornerstone of its brand division.

Related Content

Topics

UsernamePublicRestriction

Register

PS061188

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