Pink Sheet 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

Ista Tries To Void Vitrase NME Status: Will Less Exclusivity Mean More?

Executive Summary

Ista is requesting its hyaluronidase product Vitrase be downgraded from new molecular entity status in order to obtain more meaningful exclusivity

You may also be interested in...



Omnitrope Lawsuit Could Further Delay FDA “Follow-On” Biologics Guidance

Sandoz' lawsuit against FDA over the human growth hormone product Omnitrope could further complicate the agency's efforts to define a potential approval route for "follow-on" biologics

Omnitrope Lawsuit Could Further Delay FDA “Follow-On” Biologics Guidance

Sandoz' lawsuit against FDA over the human growth hormone product Omnitrope could further complicate the agency's efforts to define a potential approval route for "follow-on" biologics

USP Human Growth Hormone Monographs Issued; Generics Status Unresolved

U.S. Pharmacopeia's release of monographs on human growth hormone appears unlikely to significantly advance the debate over an abbreviated pathway for HGH follow-on products

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS045715

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