FDA accepts Dacogen NDA as complete response
MGI PHARMA and fellow US drugmaker SuperGen say that the Food and Drug Administration have accepted their application for Dacogen (decitabine) injection as a treatment for myelodysplastic syndromes as a complete response to the approvable letter they previously issued (Marketletter November 21, 2005).
The FDA has classified the resubmission as a Class 2 response, and has established a user fee goal to review this by May 15. The product, which belongs to a class of drugs called hypomethylating agents, is currently being evaluated in a broad clinical development program in patients with MDS, acute myeloid leukemia, chronic myelogenous leukemia and solid tumors.
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
Copyright © The Pharma Letter 2024 | Headless Content Management with Blaze