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

Teva Gets Exclusivity For Generic Kytril; FDA Still Worries About Racing, Parking

Executive Summary

In granting Teva 180-day marketing exclusivity for its generic formulation of Roche's antinausea drug Kytril (granisetron), FDA has laid out initial ground rules for determining when ANDA holders forfeit exclusivity

You may also be interested in...



ANDA Filing Free-For-All? Matrix's Stay In Kaletra Case Could Remove Risks Of Submitting Early Dual Certification Generic Drug Applications

Matrix's ability to win a stay of litigation over Kaletra patents - and thus avoid a potential forfeit of its generic exclusivity - suggests a possible strategy for other early ANDA filers

ANDA Filing Free-For-All? Matrix's Stay In Kaletra Case Could Remove Risks Of Submitting Early Dual Certification Generic Drug Applications

Matrix's ability to win a stay of litigation over Kaletra patents - and thus avoid a potential forfeit of its generic exclusivity - suggests a possible strategy for other early ANDA filers

ANDA Reviews: Inspector General Weighs In, But Progress Depends On Congress

A report by the HHS Office of Inspector General on FDA's review process for generic drugs illuminates the challenges the agency faces, but reaction to the report underscores the impression that complete resolution of the issue will require Congressional intervention

Related Content

UsernamePublicRestriction

Register

LL1134940

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