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

Everything Old Is New Again: History Of Compounding Shaped Ampyra REMS

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Acorda’s Ampyra (dalfampridine) is a first-in-class new molecular entity in terms of FDA approval, but the drug substance’s history as a compounded drug raised the concerns necessitating a Risk Evaluation and Mitigation Strategy, FDA’s review documents show.

You may also be interested in...



Ampyra Trial Failure Is Not All Bad News For Acorda

Lower dose of Acorda’s MS drug Ampyra fails to meet primary endpoint in new study, reassuring investors on the IP front. But the higher, approved dose also missed the mark, which raises questions about a negative commercial impact.

Ampyra Trial Failure Is Not All Bad News For Acorda

Lower dose of Acorda’s MS drug Ampyra fails to meet primary endpoint in new study, reassuring investors on the IP front. But the higher, approved dose also missed the mark, which raises questions about a negative commercial impact.

Ampyra Trial Failure Is Not All Bad News For Acorda

Lower dose of Acorda’s MS drug Ampyra fails to meet primary endpoint in new study, reassuring investors on the IP front. But the higher, approved dose also missed the mark, which raises questions about a negative commercial impact.

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS004449

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