Click here to close now.

SYS-CON MEDIA Authors: Cloud Best Practices Network, Kevin Jackson, Pat Romanski, XebiaLabs Blog, Sematext Blog

News Feed Item

Astellas Pharma US, Inc. reaches agreement with U.S. Department of Justice

NORTHBROOK, Ill., April 16, 2014 /PRNewswire/ -- Astellas Pharma US, Inc. ("Astellas"), a U.S. subsidiary of Tokyo-based Astellas Pharma Inc. (Tokyo: 4503), announced today that it has reached an agreement with the U.S. Department of Justice to resolve civil claims regarding the marketing of MYCAMINE® (micafungin sodium) for injection.  Under the agreement, Astellas will pay $7.3 million to the settling parties.

The Department of Justice had investigated Astellas for alleged off-label promotion of MYCAMINE for pediatric use, a claim the company has consistently denied.  MYCAMINE is an injectable drug used to treat or prevent certain serious fungal infections and, at the time of the investigation, had not yet been approved for pediatric use in the United States.  MYCAMINE received approval by the U.S. Food and Drug Administration (FDA) in June, 2013 for use in children four months and older.

Said Astellas Pharma US, Inc. CEO Masao Yoshida, "Astellas cooperated fully with the U.S. Government's review of this matter, and we are pleased to have reached a resolution."  He continued, "In keeping with our corporate commitment to conduct business with a high sense of ethics, our policy has always been to promote our products in accordance with FDA regulations."

Indications and Usage:
MYCAMINE is indicated in adults and pediatric patients four months and older for:

  • Treatment of patients with candidemia, acute disseminated candidiasis, Candida peritonitis and abscesses.
    • MYCAMINE has not been adequately studied in patients with endocarditis, osteomyelitis and meningitis due to Candida infections
  • Treatment of patients with esophageal candidiasis
  • Prophylaxis of Candida infections in patients undergoing hematopoietic stem cell transplantation
    • NOTE:  The efficacy of MYCAMINE against infections caused by fungi other than Candida has not been established.

Important Safety Information for MYCAMINE® (micafungin sodium) for Injection

MYCAMINE is contraindicated in patients with known hypersensitivity to micafungin sodium, any component of MYCAMINE, or other echinocandins.

Isolated cases of serious hypersensitivity (anaphylaxis and anaphylactoid) reactions (including shock) have been reported in patients receiving MYCAMINE.  In these cases, MYCAMINE should be discontinued and administer appropriate treatment.

Elevations in BUN and creatinine, isolated cases of clinically significant hepatic dysfunction, hepatitis, hepatic failure, renal dysfunction, acute renal failure, hemolysis, or hemolytic anemia have occurred in some patients who have received MYCAMINE.  Patients who develop these conditions, or abnormal liver or renal function tests, should be monitored closely for worsening function and evaluated for risk/benefit of continuing MYCAMINE therapy.

In clinical trials, possible histamine-mediated symptoms have been reported with MYCAMINE (including rash, pruritus, facial swelling, and vasodilatation).

In clinical trials, the most common treatment-emergent adverse reactions in adults for all indications included diarrhea, nausea, vomiting, pyrexia, thrombocytopenia, and headache.  The most common treatment-emergent adverse reactions observed in pediatric patients four months and older included vomiting, diarrhea, pyrexia, nausea, abdominal pain and thrombocytopenia.

Please see complete Prescribing Information for MYCAMINE.

About Astellas Pharma US, Inc.

Astellas Pharma US, Inc., located in Northbrook, Illinois, is a U.S. affiliate of Tokyo-based Astellas Pharma Inc.  Astellas is a pharmaceutical company dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceutical products.  The organization is committed to becoming a global category leader in focused areas.  For more information about Astellas Pharma US, Inc., please visit our website at www.astellas.us.

SOURCE Astellas Pharma US, Inc.

More Stories By PR Newswire

Copyright © 2007 PR Newswire. All rights reserved. Republication or redistribution of PRNewswire content is expressly prohibited without the prior written consent of PRNewswire. PRNewswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

Latest Stories
DevOps tends to focus on the relationship between Dev and Ops, putting an emphasis on the ops and application infrastructure. But that’s changing with microservices architectures. In her session at DevOps Summit, Lori MacVittie, Evangelist for F5 Networks, will focus on how microservices are changing the underlying architectures needed to scale, secure and deliver applications based on highly distributed (micro) services and why that means an expansion into “the network” for DevOps.
In the consumer IoT, everything is new, and the IT world of bits and bytes holds sway. But industrial and commercial realms encompass operational technology (OT) that has been around for 25 or 50 years. This grittier, pre-IP, more hands-on world has much to gain from Industrial IoT (IIoT) applications and principles. But adding sensors and wireless connectivity won’t work in environments that demand unwavering reliability and performance. In his session at @ThingsExpo, Ron Sege, CEO of Echelon...
With several hundred implementations of IoT-enabled solutions in the past 12 months alone, this session will focus on experience over the art of the possible. Many can only imagine the most advanced telematics platform ever deployed, supporting millions of customers, producing tens of thousands events or GBs per trip, and hundreds of TBs per month. With the ability to support a billion sensor events per second, over 30PB of warm data for analytics, and hundreds of PBs for an data analytics arc...
We’re no longer looking to the future for the IoT wave. It’s no longer a distant dream but a reality that has arrived. It’s now time to make sure the industry is in alignment to meet the IoT growing pains – cooperate and collaborate as well as innovate. In his session at @ThingsExpo, Jim Hunter, Chief Scientist & Technology Evangelist at Greenwave Systems, will examine the key ingredients to IoT success and identify solutions to challenges the industry is facing. The deep industry expertise be...
Between the compelling mockups and specs produced by your analysts and designers, and the resulting application built by your developers, there is a gulf where projects fail, costs spiral out of control, and applications fall short of requirements. In his session at DevOps Summit, Charles Kendrick, CTO and Chief Architect at Isomorphic Software, will present a new approach where business and development users collaborate – each using tools appropriate to their goals and expertise – to build mo...
Operational Hadoop and the Lambda Architecture for Streaming Data Apache Hadoop is emerging as a distributed platform for handling large and fast incoming streams of data. Predictive maintenance, supply chain optimization, and Internet-of-Things analysis are examples where Hadoop provides the scalable storage, processing, and analytics platform to gain meaningful insights from granular data that is typically only valuable from a large-scale, aggregate view. One architecture useful for capturing...
The Internet of Things (IoT) is causing data centers to become radically decentralized and atomized within a new paradigm known as “fog computing.” To support IoT applications, such as connected cars and smart grids, data centers' core functions will be decentralized out to the network's edges and endpoints (aka “fogs”). As this trend takes hold, Big Data analytics platforms will focus on high-volume log analysis (aka “logs”) and rely heavily on cognitive-computing algorithms (aka “cogs”) to mak...
When it comes to the Internet of Things, hooking up will get you only so far. If you want customers to commit, you need to go beyond simply connecting products. You need to use the devices themselves to transform how you engage with every customer and how you manage the entire product lifecycle. In his session at @ThingsExpo, Sean Lorenz, Technical Product Manager for Xively at LogMeIn, will show how “product relationship management” can help you leverage your connected devices and the data th...
The Internet of Everything (IoE) brings together people, process, data and things to make networked connections more relevant and valuable than ever before – transforming information into knowledge and knowledge into wisdom. IoE creates new capabilities, richer experiences, and unprecedented opportunities to improve business and government operations, decision making and mission support capabilities. In his session at @ThingsExpo, Gary Hall, Chief Technology Officer, Federal Defense at Cisco S...
For years, we’ve relied too heavily on individual network functions or simplistic cloud controllers. However, they are no longer enough for today’s modern cloud data center. Businesses need a comprehensive platform architecture in order to deliver a complete networking suite for IoT environment based on OpenStack. In his session at @ThingsExpo, Dhiraj Sehgal from PLUMgrid will discuss what a holistic networking solution should really entail, and how to build a complete platform that is scalable...
Big Data is amazing, it's life changing and yes it is changing how we see our world. Big Data, however, can sometimes be too big. Organizations that are not amassing massive amounts of information and feeding into their decision buckets, smaller data that feeds in from customer buying patterns, buying decisions and buying influences can be more useful when used in the right way. In their session at Big Data Expo, Ermanno Bonifazi, CEO & Founder of Solgenia, and Ian Khan, Global Strategic Positi...
SYS-CON Media announced today that XebiaLabs launched a popular blog feed on DevOps Journal with close to 2,000 story reads in less than a day. DevOps Journal is focused on this critical enterprise IT topic in the world of cloud computing. DevOps Journal brings valuable information to DevOps professionals who are transforming the way enterprise IT is done.
One of the biggest impacts of the Internet of Things is and will continue to be on data; specifically data volume, management and usage. Companies are scrambling to adapt to this new and unpredictable data reality with legacy infrastructure that cannot handle the speed and volume of data. In his session at @ThingsExpo, Don DeLoach, CEO and president of Infobright, will discuss how companies need to rethink their data infrastructure to participate in the IoT, including: Data storage: Understand...
Cloudian, Inc., the leading provider of hybrid cloud storage solutions, today announced availability of Cloudian HyperStore 5.1 software. HyperStore 5.1 is an enhanced Amazon S3-compliant, plug-and-play hybrid cloud software solution that now features full Apache Hadoop integration. Enterprises can now transform big data into smart data by running Hadoop analytics on HyperStore software and appliances. This in-place analytics, with no need to offload data to other systems for Hadoop analyses, en...
Since 2008 and for the first time in history, more than half of humans live in urban areas, urging cities to become “smart.” Today, cities can leverage the wide availability of smartphones combined with new technologies such as Beacons or NFC to connect their urban furniture and environment to create citizen-first services that improve transportation, way-finding and information delivery. In her session at @ThingsExpo, Laetitia Gazel-Anthoine, CEO of Connecthings, will focus on successful use c...