US FDA accepts Epanova NDA filing
Anglo-Swedish drug major AstraZeneca (LSE: AZN) today announced that the US Food and Drug Administration (FDA) has accepted for review a New Drug Application for Epanova, an investigational compound for the treatment for patients with severe hypertriglyceridemia (triglyceride levels greater than or equal to 500mg/dL).
The NDA submission for Epanova was filed by USA-based Omthera Pharmaceuticals, which AstraZeneca acquired for an upfront $323 million, in a deal worth a potential $433 million including contingency payments (The Pharma Letter May 28), as a 505(b)(1) application in July 2013. The Prescription Drug User Fee Act (PDUFA) goal date for the FDA is May 5, 2014.
Omthera holds worldwide rights to Epanova under a license from Chrysalis Pharma AG, a privately held Swiss company that is the owner of the product.
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.
Login to your accountTry before you buy
Free
7 day trial access
- 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
- 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
Today's issue
Company Spotlight
More Features in Pharmaceutical
Copyright © The Pharma Letter 2024 | Headless Content Management with Blaze