Scrip 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

Mylan Preparing Response To Generic Advair CRL, And It Needs A Win

Executive Summary

After meeting with FDA to discuss the status of its Advair generic application in the US, Mylan said it will not have to conduct additional clinical trials and is on target to respond to the complete response letter soon.

Advertisement

Related Content

Three Strikes For Generic Advair With An FDA CRL For Sandoz
Three Strikes For Generic Advair With An FDA CRL For Sandoz
Surprise! Mylan's Copaxone Generic Sets Teva Up For A Struggle
Surprise! Mylan's Copaxone Generic Sets Teva Up For A Struggle
Keeping Track: Zelboraf Takes Breakthrough Path For Rare Blood Disease; Teva Resubmits Generic EpiPen
Mylan Suggests Downside To FDA's Efforts To Improve Generic Drug Review
Generic Manufacturers Try To Up Their Game As US Pressure Persists
Hikma's CRL Proves GSK's Witty Was Right: Generic Advair Is Hard
Mylan’s Generic Advair Delay Gives Leverage To Rivals
Mylan’s Growth Strategy: Diversification, Expansion And R&D Investment

Topics

Related Companies

Advertisement
UsernamePublicRestriction

Register

SC099294

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