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

Pancreatic Insufficiency Drug Makers Given NDA Approval Deadline Of 2008

This article was originally published in The Pink Sheet Daily

Executive Summary

FDA is not removing unapproved products from the market because they are medically necessary. However, manufacturers must obtain approval of exocrine pancreatic insufficiency drugs within four years.

You may also be interested in...



Lilly's Pancreatic Enzyme Replacement Therapy Faces Advisory Committee Scrutiny

FDA's Gastrointestinal Drugs panel's Jan. 12 review of Solpura (liprotamase) is likely to focus on robustness of efficacy results and relevant endpoints.

Lilly's Pancreatic Enzyme Replacement Therapy Faces Advisory Committee Scrutiny

FDA's Gastrointestinal Drugs panel's Jan. 12 review of Solpura (liprotamase) is likely to focus on robustness of efficacy results and relevant endpoints.

Market Snapshot: Pancreatic Enzyme Products Get A Lift From FDA Rules

Specialty pharma Eurand's official launch of its pancreatic enzyme product Zenpep at the end of November marks the entry of the second product to meet tighter FDA standards required by 2010

Related Content

Topics

Latest News
See All
UsernamePublicRestriction

Register

PS059250

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