Navigation Links
Mylan Receives Approval for First-to-File Generic Keppra XR® Extended-Release Tablets
Date:12/27/2011

PITTSBURGH, Dec. 27, 2011 /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 Levetiracetam Extended-release (ER) Tablets, 500 mg and 750 mg. This product is the generic version of UCB's Keppra XR® Tablets, which are a treatment for partial onset seizures in patients over 16 years of age with epilepsy. 

Levetiracetam ER Tablets had U.S. sales of approximately $162.8 million for the 12 months ending Sept. 30, 2011, according to IMS Health. Mylan is shipping this product immediately.

Currently, Mylan has 170 ANDAs pending FDA approval representing $98.4 billion in annual sales, according to IMS Health. Forty-two of these pending ANDAs are potential first-to-file opportunities, representing $26.8 billion in annual brand sales, for the 12 months ending June 30, 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 respiratory, allergy and psychiatric therapies. For more information about Mylan, please visit www.mylan.com. For more information about generic drugs, please visit www.ChoosingGenerics.com.

 

 


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

Page: 1

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)... LAS VEGAS , July 13, 2017 It ... the United States is in the midst of ... Disease Control , since 1999, the number of overdose deaths ... , "resulting in over half a million dead from 2001 ... like codeine, oxycodone, and hydrocodone has similarly quadrupled, drawing a ...
(Date:7/12/2017)... -- Eli Lilly and Company (NYSE: LLY ) has ... pending patent litigation in the U.S. District Court for the ... Cialis ® (tadalafil) unit dose patent. This patent was ... of the agreement, Cialis exclusivity is now expected to end ... unit dose patent for Cialis is valid and infringed by ...
(Date:7/11/2017)... 11, 2017  Dr. Echenberg, founder of Echenberg Institute, is announcing a ... who suffer from painful intercourse and other painful pelvic pain conditions such ... to menopause. ... LLC ... Sarasota, Florida -based start-up company, VuVatech LLC, fills a void ...
Breaking Medicine Technology:
(Date:7/20/2017)... ... July 19, 2017 , ... Western ... Resources and Services Administration (HRSA) grant to train predoctoral dental students in providing ... in rural and underserved areas. , The Predoctoral Pediatric Training Project (PPTP), a ...
(Date:7/20/2017)... ... , ... A July 5th article on Reuters Health News discusses ... a body contouring procedure reported experiencing a better quality of life, compared to other ... both types of procedures, notes that this report jibes with what they regularly hear ...
(Date:7/20/2017)... (PRWEB) , ... July 20, 2017 , ... “Fidget”: a ... Sisk, a retired public high school music and drama teacher who was a summa ... educational career, including a “Teacher of the Year” award. After her retirement from public ...
(Date:7/18/2017)... (PRWEB) , ... July 18, 2017 , ... CannaKids, a ... extracted cannabis oils, announced today that at the WORLDZ Summit, taking place in ... speaking on the therapeutic benefits of medical cannabis for both pediatric and adult patients, ...
(Date:7/18/2017)... ... 18, 2017 , ... ClinicalTrials.gov and the New Final Rule ... Consider?, **An FDAnews Webinar**, Aug. 2, 2017 — 1:30 p.m. – 3:00 p.m. ... Clinical Trials Registration and Results Information,” is a head-scratcher. After reading and re-reading ...
Breaking Medicine News(10 mins):