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

Symlin Dose Titration Mitigates Hypoglycemia, Nausea, Amylin Says

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Amylin’s recent Symlin NDA amendment shows that a dose titration regimen reduces the risks of nausea and hypoglycemia in type 1 and 2 diabetes patients, the firm reported June 15.

You may also be interested in...



Estimated FDA User Fee Review Goals For Pending NDAs/BLAs

 

Watchdog Group Revives Concerns Over Symlin Dosing Instructions

FDA's internal review of the dosing instructions for Amylin's antidiabetic Symlin likely will revisit dosing-related concerns first identified during its NDA review

Symlin Complete Response Follows "Emerging Consensus" On Hypoglycemia

Amylin expects its hypoglycemia re-analysis to mitigate FDA’s concerns about its pending antidiabetic Symlin, the company says.

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS002308

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