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

Amylin’s Symlin Diabetes Therapy Gets FDA Nod

This article was originally published in The Pink Sheet Daily

Executive Summary

The approval follows the company’s submission of a re-analysis of hypoglycemia data in response to an FDA “approvable” letter. The product is approved as an adjunct treatment for Type 1 and 2 diabetes.

You may also be interested in...



Amylin Halts Development Of Symlin With Approved Appetite Suppressants

The 2009 filing timeline for once-weekly exenatide could be hastened if FDA does not require bioequivalence data, firm says.

Amylin Halts Development Of Symlin With Approved Appetite Suppressants

The 2009 filing timeline for once-weekly exenatide could be hastened if FDA does not require bioequivalence data, firm says.

Amylin Obesity Combo Scores Big Weight Loss In Phase IIa Trial

Subjects taking pramlintide/metreleptin lost a significant 12.7 percent of body weight compared with 8.4 percent for subjects on pramlintide alone.

Related Content

Topics

UsernamePublicRestriction

Register

ID1131516

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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