|By PR Newswire||
|August 19, 2014 11:42 AM EDT||
PITTSBURGH, Aug. 19, 2014 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) announced that its business Mylan Institutional has launched Dexmedetomidine Hydrochloride Injection, 100 mcg (base)/mL, packaged in 200 mcg (base)/2 mL Single-dose Vials, which is therapeutically equivalent to Hospira's Precedex™. Mylan yesterday received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for this product, which is indicated for the sedation of non-intubated patients prior to and/or during surgical and other procedures, and began shipping immediately.
Mylan CEO Heather Bresch commented: "Mylan's launch of a therapeutically equivalent version of Precedex Injection, another of a number of key approvals that had been pending with FDA, represents an important addition to Mylan's injectables portfolio and growing line of products in the anesthesia and pain management category. As we continue to bring a high quality, reliable supply of injectable products to the U.S. market, Mylan looks forward to delivering on its promise of providing quality medicine and service excellence in the increasingly important institutional space."
Dexmedetomidine Hydrochloride Injection, 100 mcg (base)/mL, packaged in 200 mcg (base)/2 mL Single-dose Vials, had U.S. sales of approximately $156.2 million for the 12 months ending June 30, 2014, according to IMS Health.
Currently, Mylan has 295 ANDAs pending FDA approval representing $105.8 billion in annual sales, according to IMS Health. Forty-three of these pending ANDAs are potential first-to-file opportunities, representing $25.0 billion in annual brand sales, for the 12 months ending December 31, 2013, according to IMS Health.
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
This press release includes statements that constitute "forward-looking statements," including with regard to sales of products. These statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Because such statements inherently involve risks and uncertainties, actual future results may differ materially from those expressed or implied by such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to: strategies by competitors or other third parties to delay or prevent product introductions; risks inherent in legal and regulatory processes; and the other risks detailed in the company's filings with the Securities and Exchange Commission. The company undertakes no obligation to update these statements for revisions or changes after the date of this release.
SOURCE Mylan Inc.
SYS-CON Events announced today that Gridstore™, the leader in software-defined storage (SDS) purpose-built for Windows Servers and Hyper-V, will exhibit at SYS-CON's 15th International Cloud Expo®, which will take place on November 4–6, 2014, at the Santa Clara Convention Center in Santa Clara, CA. Gridstore™ is the leader in software-defined storage purpose built for virtualization that is desig...
Oct. 30, 2014 11:45 AM EDT Reads: 2,376
SYS-CON Events announces a new pavilion on the Cloud Expo floor where WebRTC converges with the Internet of Things. Pavilion will showcase WebRTC and the Internet of Things. The Internet of Things (IoT) is the most profound change in personal and enterprise IT since the creation of the Worldwide Web more than 20 years ago. All major researchers estimate there will be tens of billions devices--co...
Oct. 30, 2014 11:45 AM EDT Reads: 1,978
For better or worse, DevOps has gone mainstream. All doubt was removed when IBM and HP threw up their respective DevOps microsites. Where are we on the hype cycle? It's hard to say for sure but there's a feeling we're heading for the "Peak of Inflated Expectations". What does this mean for the Enterprise? Should they avoid DevOps? Definitely not. Should they be cautious though? Absolutely. The tru...
Oct. 30, 2014 11:45 AM EDT Reads: 1,879
The only place to be June 9-11 is Cloud Expo & @ThingsExpo 2015 East at the Javits Center in New York City. Join us there as delegates from all over the world come to listen to and engage with speakers & sponsors from the leading Cloud Computing, IoT & Big Data companies. Cloud Expo & @ThingsExpo are the leading events covering the booming market of Cloud Computing, IoT & Big Data for the enterp...
Oct. 30, 2014 11:45 AM EDT Reads: 231
SYS-CON Events announced today that Cloudian, Inc., the leading provider of hybrid cloud storage solutions, has been named “Bronze Sponsor” of SYS-CON's 15th International Cloud Expo®, which will take place on November 4–6, 2014, at the Santa Clara Convention Center in Santa Clara, CA. Cloudian is a Foster City, Calif.-based software company specializing in cloud storage. Cloudian HyperStore® is ...
Oct. 30, 2014 11:45 AM EDT Reads: 1,749
SYS-CON Events announced today that Grid Dynamics, the leading provider of scalable eCommerce technology solutions, will exhibit at DevOps Summit Silicon Valley, which will take place on November 4–6, 2014, at the Santa Clara Convention Center in Santa Clara, CA. Grid Dynamics is a leading provider of open, scalable, next-generation commerce technology solutions for Tier 1 retail. Grid Dynamics h...
Oct. 30, 2014 11:30 AM EDT Reads: 579
SYS-CON Events announced today that Serena Software will exhibit at DevOps Summit Silicon Valley, which will take place on November 4–6, 2014, at the Santa Clara Convention Center in Santa Clara, CA. Serena Software supports DevOps and Continuous Delivery by providing application deployment automation and software release management solutions to replace slow and error-prone manual processes. 2,500...
Oct. 30, 2014 11:30 AM EDT Reads: 1,542
Docker offers a new, lightweight approach to application portability. Applications are shipped using a common container format and managed with a high-level API. Their processes run within isolated namespaces that abstract the operating environment independently of the distribution, versions, network setup, and other details of this environment. This "containerization" has often been nicknamed "th...
Oct. 30, 2014 11:00 AM EDT Reads: 1,653
The 4th International DevOps Summit, co-located with16th International Cloud Expo – being held June 9-11, 2015, at the Javits Center in New York City, NY – announces that its Call for Papers is now open. Born out of proven success in agile development, cloud computing, and process automation, DevOps is a macro trend you cannot afford to miss. From showcase success stories from early adopters and ...
Oct. 30, 2014 11:00 AM EDT Reads: 1,758
When an enterprise builds a hybrid IaaS cloud connecting its data center to one or more public clouds, security is often a major topic along with the other challenges involved. Security is closely intertwined with the networking choices made for the hybrid cloud. Traditional networking approaches for building a hybrid cloud try to kludge together the enterprise infrastructure with the public clou...
Oct. 30, 2014 11:00 AM EDT Reads: 1,320