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

FDA Elimination Of Neoral "Microemulsion" Designation Disputed By Novartis

Executive Summary

FDA's elimination of "microemulsion" dosage forms is unlawful, Novartis contended in a Feb. 11 lawsuit challenging FDA's approval of SangStat's generic version of Neoral (cyclosporine).

You may also be interested in...



Novartis Offers Gengraf Patients Transition Monitoring If Generic Is Pulled

Novartis will offer blood level monitoring for transplant patients switching from Abbott's Gengraf to other cyclosporine products if the company's motion to have Gengraf removed from the market is granted

Novartis Offers Gengraf Patients Transition Monitoring If Generic Is Pulled

Novartis will offer blood level monitoring for transplant patients switching from Abbott's Gengraf to other cyclosporine products if the company's motion to have Gengraf removed from the market is granted

Abbott/SangStat May Launch Oral Solution Gengraf To Replace SangCya

SangStat and Abbott are considering launching Abbott's generic cyclosporine oral solution Gengraf following the July 10 recall of SangStat's cyclosporine SangCya, the companies said.

Related Content

Latest Headlines
See All
UsernamePublicRestriction

Register

PS033655

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