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.

Menu

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
My View
Tags:

Symlin "approvable" letter

  • News

Executive Summary

Amylin will conduct additional trials of antidiabetic Symlin (pramlintide) prior to approval. The trials could focus on dose titration. Amylin is discussing clinical protocol for further studies with FDA after the agency deemed the product "approvable" Oct. 12

You may also be interested in...



Amylin Exenatide NDA Filing Expected Mid-2004; Symlin Launch in Q1

Amylin is eyeing a mid-2004 filing date for its exenatide NDA

Amylin Exenatide NDA Filing Expected Mid-2004; Symlin Launch in Q1

Amylin is eyeing a mid-2004 filing date for its exenatide NDA

Amylin To Resubmit Symlin In June; Ex-Guidant Exec Graham Named CEO

Amylin's resubmission plans for Symlin will give the diabetes agent a chance for approval before the end of 2003

Table

View full table

Tags:
Latest Headlines

China’s Public Payer Wants To Define Innovative Drugs As Those With ‘Novel Benefits’

Change Is Constant For Pneumococcal Vaccines: US CDC Prepares For Merck’s V116

Woodcock Takes On Rare Disease Challenges In Retirement, Keeps FDA, Industry At Arm’s Length

German HTA Queries Polivy Benefits Amid Lack Of Evidence

See All
UsernamePublicRestriction

Register

PS038683

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

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