Navigation Links
Mylan Launches First Generic Version of Lescol® Capsules
Date:4/13/2012

PITTSBURGH, April 13, 2012 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) today announced that its subsidiary Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (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.[1]   

Pursuant to a settlement and license agreement 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 approximately $27.9 million for the 12 months ending Dec. 31, 2011, according to IMS Health. Mylan has begun shipping its generic version of this product.

Currently, Mylan has 172 ANDAs pending FDA approval representing $100.2 billion in annual sales, according to IMS Health. Forty of these pending ANDAs are potential first-to-file opportunities, representing $25.7 billion in annual brand sales, for the 12 months ending Dec. 31, 2011, according to IMS Health.

Mylan Inc. ranks among the leading generic and specialty pharmaceutical companies in the world and provides products to customers in more than 150 countries and territories. The company maintains one of the industry's broadest and highest quality product portfolios supported by a robust product pipeline; operates one of the world's largest active pharmaceutical ingredient manufacturers; and runs a specialty business focused on allergy, respiratory and psychiatric therapies. For more information about Mylan, please visit www.mylan.com. For more information about generic drugs, please visit www.ChoosingGenerics.com.

[1] Fluvastatin should not be used in patients with hypersensitivity to any component of this medication, patients with liver disease, women who are pregnant or may become pregnant or mothers who are breast feeding.


'/>"/>
SOURCE Mylan Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Mylan Announces Settlement Agreement Related to Antidepressant Effexor XR(R)
2. Mylan Receives FDA Approval for Generic Version of Parkinsons Treatment Sinemet(R)
3. Mylan Schedules Third Quarter 2009 Financial Results Conference Call and Live Webcast
4. Mylan Receives FDA Approval for Generic Version of Anticonvulsant Topamax(R) Sprinkle Capsules
5. Mylan Confirms First-to-File Patent Challenge Relating to Caduet(R)
6. Mylan Receives Approval for Generic Version of GoLytely(R)
7. Mylan Declares Quarterly Preferred Stock Dividend
8. Mylan Pre-Pays All Scheduled 2011 Term-Loan Borrowings
9. Mylan Confirms First-to-File Patent Challenge Relating to Vytorin(R) Cholesterol Medication
10. Mylans President of Europe, Middle East and Africa Elected President of European Generic Medicines Association
11. Mylan Receives Tentative FDA Approval Under PEPFAR for Matrix Laboratories New Drug Application (NDA) for Efavirenz Tablets
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:3/24/2017)... 2017 Research and Markets has announced the ... 2017 - 2035" report to their offering. ... The Deep Learning: Drug Discovery and ... of the growing market of deep learning solutions within the healthcare ... have emerged as a novel solution to generate relevant insights from ...
(Date:3/24/2017)... India , March 24, 2017 ... of the industry including definitions, classifications, applications and industry ... the international market including development history, competitive landscape analysis, ... ... Ampoules industry spread across 105 pages providing 10 company ...
(Date:3/24/2017)... Mar 24, 2017 Research and Markets has ... Strategic Business Report" report to their offering. ... The report provides separate comprehensive analytics for the ... Europe , Asia-Pacific , Latin ... provided for the period 2015 through 2022. Also, a six-year historic analysis ...
Breaking Medicine Technology:
(Date:3/24/2017)... ... March 24, 2017 , ... ... countries to hospitals in the United States, it’s a threat that is constantly ... obstacles facing infection prevention and offers strategies for the healthcare community to help ...
(Date:3/24/2017)... ... March 24, 2017 , ... Texas Physical Therapy Specialists (TexPTS) is ... 9618 Huebner Road. The clinic is the group’s 7th location in San Antonio and ... Higgins, PT, will provide care from the clinic, which opened March 22, 2017. ...
(Date:3/24/2017)... (PRWEB) , ... March 24, 2017 , ... ... over $100,000 for its innovative EcoQube Frame vertical micro-veggies garden on Kickstarter ... demand for the product – with nearly 2,000 consumers (and counting) already backing ...
(Date:3/24/2017)... NY (PRWEB) , ... March 24, 2017 , ... The ... and White Plains, N.Y., is pleased to announce Westchester resident Lauren C. Enea has ... law clerk for the firm, will concentrate her practice in elder law, Medicaid planning ...
(Date:3/24/2017)... (PRWEB) , ... March 24, 2017 , ... ... the first Certified Medical Reiki™ Master in Frederick, MD. Judy says, “I am ... caregivers during what is often a very difficult and challenging time.” , A ...
Breaking Medicine News(10 mins):