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

Cipla Files ANDA For Advair Rival

FDA Will Now Consider Indian Firm’s Version Alongside Hikma

Executive Summary

Cipla has revealed that it has now filed its ANDA for a US rival to Advair Diskus. The FDA is already considering Hikma’s generic, while Mylan’s Wixela Inhub version has been on the market for well over a year.

You may also be interested in...



Cipla Lines Up Advair But Costs Will Flatten High-Value Launches

A generic version of Advair is high on Cipla’s plans for its current financial year ending in March 2023. Management discussed the high-value respiratory asset and the company’s further prospects during the Indian firm’s annual earnings call, which included the company passing $1bn in sales for its domestic branded prescription business.

Cipla Remains Upbeat On Abraxane As US Generic Competition Looms

Cipla has provided the latest on its US complex pipeline ahead of several potential launches in the firm’s upcoming 2022/23 financial year. The Indian firm enjoyed 6% group revenue growth in Q3 FY2022 and is on track to hit its EBITDA margin target.

Hikma Resumes Launch Of Advair Rival

Hikma has restarted launch activities for its generic version of GSK’s Advair respiratory blockbuster in the US, after the FDA gave the go-ahead following approval of an ANDA amendment.

Related Content

Topics

Related Companies

Latest News
UsernamePublicRestriction

Register

GB149900

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