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

FDA Nixes Innovator Industry-Backed Changes To Citizen Petition Rule

Executive Summary

Agency rejects PhRMA requests to ease certification process and limit rule's application; separately, law firm Hyman, Phelps & McNamara objects to FDA practice of delaying ANDA approval announcements until it issues a petition decision.

You may also be interested in...



Crestor Generics To Launch After 12-Day Delay

AstraZeneca's legal gambit results in almost two more weeks of sales for the statin even though the court ultimately agreed with FDA on labeling carve-out for orphan indication.

AstraZeneca Sues FDA On Crestor Generics: Fighting A 'Foregone Conclusion'?

Company is waging the same legal battle Otsuka lost last year, arguing pediatric orphan indication should block approvals of ANDAs.

180-Day Exclusivity Ruling On Cosopt Signals Need For Strong Patent Challenges

FDA's decision that Hi-Tech forfeited its generic exclusivity for Merck's ophthalmic Cosopt (dorzolamide/timolol) means that firms may need to give more weight to the strength of their patent challenges as they make filing decisions in the future

Topics

Related Companies

UsernamePublicRestriction

Register

PS119470

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