Hospira receives FDA approval for generic of The Medicines Company's Angiomax
Biosimilar injectables specialist Hospira (NYSE: HSP) has obtained approval from the US Food and Drug Administration for bivalirudin, a generic of Angiomax from The Medicines Company (Nasdaq: MDCO).
Bivalirudin is a direct thrombin inhibitor, indicated for use as an anticoagulant in patients with unstable angina undergoing percutaneous transluminal coronary angioplasty, undergoing percutaneous coronary intervention (PCI) with provisional use of glycoprotein IIb/IIIa inhibitor, and with, or at risk of, heparin-induced thrombocytopenia or heparin-induced thrombocytopenia and thrombosis syndrome, undergoing PCI.
The drug is available from Hospira as a single-dose flip-top vial, matching the current branded offering. The company also plans to launch a differentiated presentation of the 250mg formulation for injection in its ADD-Vantage vial.
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 Generics
Copyright © The Pharma Letter 2024 | Headless Content Management with Blaze