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:7/14/2017)... plc (NASDAQ: ENDP ) will announce its second-quarter 2017 ... management team will host a conference call and webcast before the ... The dial-in number to access the call is U.S./ Canada ... 45397076. Please dial in 10 minutes prior to the scheduled start ... the call will be available from August 8, 2017 at 11:30 ...
(Date:7/13/2017)...  Centurion Medical Products, a leader in medical product innovation and ... removal device for hospice patient care. ... Centurion Medical Products ... Patient pain management and emotional comfort are part of a ... pain while preventing unneeded emergency department admission due to severe fecal ...
(Date:7/13/2017)... Md. , July 13, 2017  New York City-based ... of pharmaceutical markets should be aware of.  From new products ... trends are detailed in a recently completed study, Potential ... 1.  Age-Driven Growth ... we have been aware of the impact the growing population ...
Breaking Medicine Technology:
(Date:7/24/2017)... ... July 24, 2017 , ... Peruvian Ayahuasca retreat, ... be awarded annually to and divided between two full-time university students enrolled in ... Amazonian plant medicine. To apply for the scholarship, students are asked to submit ...
(Date:7/24/2017)... ... 24, 2017 , ... The Topricin Companies, formerly Topical Biomedics, ... revolutionary, natural, after-burn skin care product, Topricin After Burn Cream. , ... skin conditions, including cancer. In the short term, overexposure to sun, wind ...
(Date:7/24/2017)... Switzerland (PRWEB) , ... July 24, 2017 , ... Anyone ... to weigh a watermelon, nor would a pharmacist using that same scale to dispense ... risk someone’s health. , These illustrations show why it is important to have ...
(Date:7/24/2017)... ... 2017 , ... Paul Vitenas, MD, FACS is excited to report that he ... attend Allergan’s recent meeting with their Plastics Advisory Board. As one of the top ... bringing a newly defined structure to the aesthetics market. Dr. Vitenas , along ...
(Date:7/24/2017)... ... ... Summer storms are inevitable as weather temperatures in Philadelphia climb. These ... tree damage requiring emergency tree service. Giroud Tree and Lawn provides ... hazardous tree removal. , “A summer storm is like a bully on ...
Breaking Medicine News(10 mins):