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

Advair Competition: Teva’s AirDuo Approved But Not Therapeutically Equivalent

Executive Summary

US FDA approves Teva’s fluticasone/salmeterol fixed-dose combination product under the 505(b)(2) NDA route with an asthma indication but no labeling claim for chronic obstructive pulmonary disease.

You may also be interested in...



Advair Generic Approval Uncertain Despite US FDA Denial Of Sandoz Petition

Agency declined to say whether ANDA sponsors would need to meet requirements requested by Sandoz; Mylan's generic user fee date is March 28.

Advair Generic Approval Uncertain Despite US FDA Denial Of Sandoz Petition

Agency declined to say whether ANDA sponsors would need to meet requirements requested by Sandoz; Mylan's generic user fee date is March 28.

Keeping Track: Xermelo, Odactra, Noctiva Approved; Second Submissions For Avelumab And Deutetrabenazine

The latest drug development news and highlights from our US FDA Performance Tracker.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

PS078529

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