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

Boehringer Ingelheim’s Me-Too Petition Against Generic Spiriva

This article was originally published in The Pink Sheet Daily

Executive Summary

The company is borrowing a page, and a law firm, from GlaxoSmithKline’s 2009 citizen petition asking FDA to impose conditions on generic Advair.

You may also be interested in...



FDA Generics Director’s Departure Shows Why Chemistry Matters

Another outside candidate is expected to eventually take over for the departing director Gregory Geba, and while the Office of Generic Drugs can run smoothly without a permanent leader for now, it cannot do so forever.

New COPD Candidates Could Get Hung Up On Safety Concerns

FDA is facing several novel candidates for chronic obstructive pulmonary disease in 2013; those products should expect close scrutiny due to past issues with class safety and new signals in clinical trials.

New COPD Candidates Could Get Hung Up On Safety Concerns

FDA is facing several novel candidates for chronic obstructive pulmonary disease in 2013; those products should expect close scrutiny due to past issues with class safety and new signals in clinical trials.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

PS073542

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