Scrip 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’s Generic Advair Delay Gives Leverage To Rivals

Executive Summary

Mylan received a “complete response” letter from FDA on its application for a generic version of GSK’s blockbuster Advair, offering scarce details on the reason why or possible length of the delay.

You may also be interested in...



Mylan Sees Generic Advair Marathon Nearing FDA Finish Line

Company management expressed confidence its application for the first generic Advair is approvable, although the US agency didn’t clear it in October as Mylan had hoped. 

Mylan Sees Generic Advair Marathon Nearing FDA Finish Line

Company management expressed confidence its application for the first generic Advair is approvable, although the US agency didn’t clear it in October as Mylan had hoped. 

Branded Advair Breathes Another Day; Mylan Says A CRL Is On The Way For A Generic

FDA alerted Mylan to expect a complete response letter related to its ANDA for generic Advair. The company said it still could receive an approval prior to the standard 90-day time period after responding to the letter, because the application has a priority designation.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

LL1133148

Ask The Analyst

Please Note: Click here for more information on the Ask the Analyst service.

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