US FDA delays approval of Paladin’s Impavido

12 November 2013

Canada-based specialty pharmaceutical company Paladin Labs (TSX: PLB) says that the US Food and Drug Administration is extending the Prescription Drug User Fee Act (PDUFA) goal date for its New Drug Application for Impavido (miltefosine) for the treatment of cutaneous, mucosal and visceral leishmaniasis from December 19, 2013 to March 19, 2014.

During the course of recent discussions with the FDA, Paladin, itself currently the subject of a $1.6 billion takeover bid from Endo Health Solutions (Nasdaq: ENDP; The Pharma Letter November 6), submitted revisions regarding chemistry, manufacturing and control (CMC) details and other aspects related to the proposed label.

No additional studies called for at this time

This article is accessible to registered users, to continue reading please register for free. A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.

Try before you buy

Free

7 day trial access

Take a Free Trial

All the news that moves the needle in pharma and biotech
Exclusive features, podcasts, interviews, data analyses and commentary from our global network of life sciences reporters.
Receive The Pharma Letter daily news bulletin, free forever.

Become a subscriber

£820

Or £77 per month

Subscribe Now

Unfettered access to industry-leading news, commentary and analysis in pharma and biotech.
Updates from clinical trials, conferences, M&A, licensing, financing, regulation, patents & legal, executive appointments, commercial strategy and financial results.
Daily roundup of key events in pharma and biotech.
Monthly in-depth briefings on Boardroom appointments and M&A news.
Choose from a cost-effective annual package or a flexible monthly subscription

The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed

Chairman, Sanofi Aventis UK