FONT-SIZE Plus   Neg

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

Mylan Inc.'s (MYL) 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.

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
It looks like 2016 is going to be a relatively lackluster year in terms of new drug approvals. Only 18 new molecular entity drugs have been approved year-to-date compared to 32 approved during the same time frame last year. Apple Inc. plans to launch a new guide for Apple TV during a product event in California today, according to Recode. While major video partners have signed up to be a part of the new Apple TV guide, Netflix Inc. will reportedly not be participating. Wal-Mart Stores Inc. is gearing up for the upcoming holiday season by deploying an army of Holiday Helpers to help customers get through the checkout process faster during the busy period. The retailer has also increased the amount of products available through its Pickup service, lowered the price on thousand of items, and plans to expand the online assortment in the coming months.
comments powered by Disqus
Follow RTT