Welcome!

News Feed Item

Mylan Launches Generic Myfortic® Delayed-Release Tablets

- Company awarded 180 days marketing exclusivity on the 360 mg strength -

PITTSBURGH, Jan. 9, 2014 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) today announced that its U.S.-based subsidiary Mylan Pharmaceuticals Inc. has launched Mycophenolic Acid Delayed-release Tablets, 180 mg and 360 mg. This product is the generic version of Novartis' Myfortic® Delayed-release Tablets. Mylan was the first company to have filed a substantially complete Abbreviated New Drug Application (ANDA) containing a Paragraph IV patent certification for Mycophenolic Acid Delayed-release Tablets, 360 mg, and was awarded 180 days of marketing exclusivity for this strength. The company received final approval from the U.S. Food and Drug Administration (FDA) for its ANDA for this product.

Mycophenolic Acid Delayed-release Tablets, 180 mg and 360 mg, had U.S. sales of approximately $306.8 million for the 12 months ending Sept. 30, 2013, according to IMS Health. Mycophenolic Acid Delayed-release Tablets are indicated for the prophylaxis of organ rejection in adult patients receiving a kidney transplant and for the prophylaxis of organ rejection in pediatric patients 5 years of age and older who are at least 6 months post kidney transplant.(1)

Currently, Mylan has 187 ANDAs pending FDA approval representing $93.7 billion in annual sales, according to IMS Health. Forty of these pending ANDAs are potential first-to-file opportunities, representing $24 billion in annual brand sales, for the 12 months ending June 30, 2013, according to IMS Health. When including ANDAs associated with Mylan's recent acquisition of Agila, the company now has a total of 287 ANDAs pending FDA approval.

Mylan is a global pharmaceutical company committed to setting new standards in health care. Working together around the world to provide 7 billion people access to high quality medicine, we innovate to satisfy unmet needs; make reliability and service excellence a habit; do what's right, not what's easy; and impact the future through passionate global leadership. We offer a growing portfolio of more than 1,300 generic pharmaceuticals and several brand medications. In addition, we offer a wide range of antiretroviral therapies, upon which approximately 40% of HIV/AIDS patients in developing countries depend. We also operate one of the largest active pharmaceutical ingredient manufacturers and currently market products in approximately 140 countries and territories. Our workforce of more than 20,000 people is dedicated to improving the customer experience and increasing pharmaceutical access to consumers around the world. But don't take our word for it. See for yourself. See inside. mylan.com

(1) Use during pregnancy is associated with increased risk of birth defects. Women of child bearing age must be counseled regarding pregnancy prevention. Use of mycophenolic acid delayed release tablets is associated with suppression of the immune system and can increase the risk of lymphoma and other malignancies, particularly of the skin.  There is also an increased risk of bacterial, viral, fungal, and protozoal infections.

SOURCE Mylan 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
Despite being the market leader, we recognized the need to transform and reinvent our business at Dynatrace, before someone else disrupted the market. Over the course of three years, we changed everything - our technology, our culture and our brand image. In this session we'll discuss how we navigated through our own innovator's dilemma, and share takeaways from our experience that you can apply to your own organization.
Blockchain has numerous revolutionary ambitions, but technology hasn’t evolved enough to make them practical. What is the best use of blockchain technology today? How are asset owners and managers looking at blockchain to transform ownership structures? How will blockchain technology allow global investors to access new markets? What kinds of companies will take advantage of blockchain technology as a more efficient way to raise capital?
This session describes how Professional Services organisations can deliver within Technology-as-a-Service (IaaS) constructs, in private and public enterprise cloud scenarios. See how professional services can be packaged and funded by IaaS cash flows, based upon consumption of technology services. Learn how significant, IT infrastructure transformations can be funded through OPEX spending models with multi-year As-a-Services based contracts. Understand how the automation of repeatable services c...
Since their inception, Total Uptime has been delivering on their promise of unprecedented uptime to major brands as well as Fortune 500 corporations in the United States and around the world. Their Cloud network spans 17 countries and delivers the unique ability to seamlessly route Internet traffic from one site to the next when our customers need us to. It is built on the best SSAE 16 SOC 2 Type 2 and CSAE 3416 Datacenters and boasts an impressive line-up of Network and Transit Provider Redunda...
​Blockchain, also known as Distributed Ledger Technology (DLT), can be used for more than just crypto currencies. This presentation discusses how blockchain and the Internet of Things (IOT) can be used for several supply chain management and logistics use cases. Real world examples that utilize the open source project Hyperledger will be discussed.
Gym Solutions is a software as a service (SaaS) solution purpose-built to service the fitness industry, with over 1000 clients servicing over 2 million gym members across 40 countries making Perfect Gym Solutions one of the largest and fastest growing SaaS applications in the fitness industry. Their platform is a comprehensive package of modern modular products for the management of fitness clubs, sports facilities and gyms an end- to end solution, revolutionising the way that gyms are managed. ...
Enterprises are universally struggling to understand where the new tools and methodologies of DevOps fit into their organizations, and are universally making the same mistakes. These mistakes are not unavoidable, and in fact, avoiding them gifts an organization with sustained competitive advantage, just like it did for Japanese Manufacturing Post WWII.
Eric Taylor, a former hacker, reveals what he's learned about cybersecurity. Taylor's life as a hacker began when he was just 12 years old and playing video games at home. Russian hackers are notorious for their hacking skills, but one American says he hacked a Russian cyber gang at just 15 years old. The government eventually caught up with Taylor and he pleaded guilty to posting the personal information on the internet, among other charges. Eric Taylor, who went by the nickname Cosmo...
There's no doubt that blockchain technology is a powerful tool for the enterprise, but bringing it mainstream has not been without challenges. As VP of Technology at 8base, Andrei is working to make developing a blockchain application accessible to anyone. With better tools, entrepreneurs and developers can work together to quickly and effectively launch applications that integrate smart contracts and blockchain technology. This will ultimately accelerate blockchain adoption on a global scale.
As the fourth industrial revolution continues to march forward, key questions remain related to the protection of software, cloud, AI, and automation intellectual property. Recent developments in Supreme Court and lower court case law will be reviewed to explain the intricacies of what inventions are eligible for patent protection, how copyright law may be used to protect application programming interfaces (APIs), and the extent to which trademark and trade secret law may have expanded relev...
The Blockchain Benchmark asks and answers the questions many people want to know about the state of Blockchain: What are the biggest barriers? What was your motivation to get involved? When will it mainstream? Who are the true influencers? What are its top use cases? Who will win over the next 5 years? How will the future unfold? And 20+ other valuable questions.
Ivo Lukas is the Founder/CEO for 24Notion. 24Notion is the first integrated marketing/digital PR & lifestyle agency with special emphasis on giving back to the global communities. With a broad understanding the art of non- traditional marketing, new media, communications and social influence. 24Notion ranked #12 in Corporate Philanthropy nominated by Portland Business Journal Book of List.
SUSE is a German-based, multinational, open-source software company that develops and sells Linux products to business customers. Founded in 1992, it was the first company to market Linux for the enterprise. Founded in 1992, SUSE is the world’s first provider of an Enterprise Linux distribution. Today, thousands of businesses worldwide rely on SUSE for their mission-critical computing and IT management needs.
Provide an overview of the capabilities of Azure Stack allowing you or your customers to adopt truly consistent Hybrid Cloud capabilities to deliver greater productivity in your cloud world. Ultan Kinahan is on a member of the Global Black Belt team at Microsoft with a focus on Azure Stack Hybrid Cloud. Ultan has been in the Azure team since the beginning, Has held roles in Engineering, Sales and now consults with both small to medium size business and the worlds largest organizations on how to ...
SAP is the world leader in enterprise applications in terms of software and software-related service revenue. Based on market capitalization, we are the world's third largest independent software manufacturer. Harness the power of your data and accelerate trusted outcome-driven innovation by developing intelligent and live solutions for real-time decisions and actions on a single data copy. Support next-generation transactional and analytical processing with a broad set of advanced analytics - r...