Generics Bulletin is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

Mylan awaits further Advair CRL

Executive Summary

Mylan will receive a second complete response letter (CRL) refusing US approval for the firm’s Wixela Inhub generic version of Advair Diskus (fluticasone/salmeterol), the firm has revealed. The US Food and Drug Administration (FDA) will communicate “minor deficiencies” identified in the company’s abbreviated new drug application (ANDA) in a CRL on 27 June, the ANDA’s target action date. No details on the nature of the CRL were revealed by Mylan or the FDA. “Because our ANDA has received a priority designation, our approval could be received prior to the standard 90-day time period following the date of our response to the CRL,” Mylan observed. Upon receipt of the CRL, Mylan said it would determine “what, if any, impact that it could have on our full-year 2018 outlook”.

You may also be interested in...



Mylan Gears Up To Launch US Advair Rival This Month

Mylan has revealed that its Wixela Inhub US rival to GSK’s Advair Diskus will be on the market by the end of February, acting quickly after their recent FDA approval.

Mylan’s Nod For US Advair Rival Puts It A Year Ahead Of The Pack

The FDA’s approval for Mylan’s Wixela Inhub generic rival to GSK’s Advair Diskus is likely to give the company around a year’s head-start on other US generics being developed by Sandoz and Hikma.

New EU Approvals

The Pink Sheet's list of EU centralized approvals of new active substances has been updated to add a new product – Tibsovo, Servier’s treatment for IDH1-mutated acute myeloid leukemia and IDH1-mutated cholangiocarcinoma.

Latest Headlines
See All
UsernamePublicRestriction

Register

GB000848

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

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