Quick Facts
FONT-SIZE Plus   Neg
Share SHARE

Mylan Unit Gets FDA Approval For First Generic Version Of Lescol Capsules

Mylan Inc.'s (MYL: Quote) subsidiary Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application or ANDA for Fluvastatin Capsules USP, 20 mg and 40 mg, the first generic version of Novartis' Lescol Capsules. This product is indicated for the treatment of both familial and nonfamilial hypercholesterolemia and mixed dyslipidemia. It is also indicated for the secondary prevention of cardiovascular disease.

According to a settlement and license deal with Novartis, Mylan was granted a license permitting launch prior to the expiration of the pediatric exclusivity associated with U.S. Patent No. 5,356,896, which expires on June 12, 2012. Lescol Capsules had U.S. sales of nearly $27.9 million for the year ending December 31, 2011, according to IMS Health. Mylan has begun shipping its generic version of this product.

Click here to receive FREE breaking news email alerts for Mylan Inc. and others in your portfolio

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
Home goods retailer Bed Bath & Beyond Inc. said Tuesday after the markets closed that its second quarter profit fell 10% from last year, as higher costs and expenses more than offset a 4.3% increase in sales. However, the company's quarterly earnings per share came in above analysts' expectations as did its quarterly sales. At the same time, With lawmakers failing to address corporate tax reform before adjourning for the campaign season, the Treasury Department announced Monday that it is taking targeted action to reduce the tax benefits of corporate tax inversions. Technology giant Apple, Inc. announced Monday it has set a new record for first weekend sales of iPhone 6 and 6 Plus, having breached the 10 million mark within just three days of its sales launch on September 19. Sales came from the U.S., Australia, Canada, France, Germany, Hong Kong, Japan, Puerto Rico, Singapore and the UK over the weekend.
comments powered by Disqus
FREE Newsletters, Analysis & Alerts

 

Stay informed with our FREE daily Newsletters and real-time breaking News Alerts. Sign up to receive the latest information on business news, health, technology, biotech, market analysis, currency trading and more.