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
Swiss drug maker Roche Holding said a late-stage trial of its breast cancer drug Kadcyla did not provide superior results compared with an existing therapy. FCA US, until recently known as Chrysler, said Friday it is recalling 257,000 Dodge Ram pickups. The auto maker says the rear axle pinion nut on certain model year 2005 Dodge Ram 1500 trucks may loosen due to an undersized spline on the pinion gear. If the pinion nut loosens, the rear axle may... This medical device company has a very impressive track record of growing business over the past decade. increasing sales from $490.2 million in 2004 to $1.72 billion this year. The Silicone Hydrogel daily disposable lens portfolio constitutes a major avenue for growth.
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.