Navigation Links
Mylan Receives Final Approval for First-to-File Generic Version of Antiepileptic Keppra(R) and Launches Immediately
Date:11/4/2008

PITTSBURGH, Nov. 4 /PRNewswire-FirstCall/ -- Mylan Inc. (NYSE: MYL) today announced that its subsidiary Mylan Pharmaceuticals Inc. received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Levetiracetam Tablets, 250 mg, 500 mg and 750 mg. Levetiracetam Tablets are the generic version of UCB Pharma's Keppra(R).

Robert J. Coury, Mylan's Vice Chairman and CEO, commented: "We are extremely pleased to be able to monetize another first-to-file opportunity and to offer a more affordable alternative for patients. In addition, after our very strong performance in the third quarter, the launch of Levetiracetam is another significant step toward the continued execution on our stated goals for 2009 and beyond."

Mylan and UCB Societe Anonyme and UCB Pharma Inc. (collectively, UCB) previously had entered into an agreement to settle pending litigation relating to Levetiracetam Tablets. Pursuant to the settlement, Mylan was given the right to market the 250 mg, 500 mg and 750 mg strengths of Levetiracetam Tablets in the United States as early as Nov. 1, 2008, provided that UCB obtained pediatric exclusivity for Keppra and Mylan's ANDA obtained final approval from the FDA. UCB was granted pediatric exclusivity relating to the '639 patent, which extends to Jan. 14, 2009. Additional terms of the settlement are confidential.

Levetiracetam Tablets had U.S. sales of approximately $1 billion for the 12 months ending Sept. 30, 2008, for these three strengths.

This press release includes statements that constitute "forward-looking statements," including with regard to the launch of Levetiracetam, the litigation settlement and expectations for future goals. These statemen
'/>"/>

SOURCE Mylan Inc.
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2

Related medicine news :

1. Mylan Declares Quarterly Preferred Stock Dividend
2. Mylans Matrix First-to-File on Generic Version of Vfend(R) Antifungal
3. Mylan to Retain Dey, L.P., Its Specialty Pharmaceutical Subsidiary
4. Mylan to Offer $400 Million in Cash Convertible Notes
5. Mylan Creates New Womens Health Care Franchise; Signs Agreement with Famy Care to Develop and Supply 22 Oral Contraceptive Products
6. Mylan Reports Adjusted Diluted EPS of $0.16 for the Quarter Ended June 30, 2008
7. Mylan Declares Quarterly Preferred Stock Dividend
8. Mylan Schedules Financial Results Conference Call and Live Webcast for the Second Quarter Fiscal 2008
9. Daniel E. Crookshank Joins Mylan as Vice President - Investor Relations
10. Mylan Announces Tentative FDA Approval for Generic Version of Antibiotic Zyvox(R) Tablets
11. Mylan Announces Final FDA Approval for Generic Version of Antidepressant Effexor(R)
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/27/2015)... ... July 27, 2015 , ... ... wound center management. Earlier this year Wound Care Advantage beta launched ... for WCA wound centers. Customized learning paths allow for clinicians, physicians, hyperbaric ...
(Date:7/27/2015)... ... , ... On July 14, 2015, Harper’s Bazaar Magazine in an article titled ... such as stretch marks , fine lines , and acne scars ... listed include lasers, ultrasound, radio frequency, Botox, and dermal fillers. It is pointed out ...
(Date:7/27/2015)... ... July 27, 2015 , ... Send ... and mobile collaboration, announced today the latest software release for ... and other feature enhancements. , This software release gives the widely used online ...
(Date:7/27/2015)... ... July 27, 2015 , ... With a new charity ... PursuitSAFETY to support its mission of reducing the number of deaths and injuries occurring ... victims and their families. PursuitSAFETY works with the police to find better and ...
(Date:7/27/2015)... ... July 27, 2015 , ... For a limited time, Huntington Beach ... whitening. Summer is a great time to change up a look or to simply ... can really affect your self-esteem. Over time, the enamel coating can become worn and ...
Breaking Medicine News(10 mins):Health News:Wound Care Advantage Launches Luvo University An Online Hub For Wound Care Education and Training 2Health News:Wound Care Advantage Launches Luvo University An Online Hub For Wound Care Education and Training 3Health News:The Latest Treatment Options for Seven Common Skin Issues 2Health News:Send Word Now Announces Release of New User Interface for its Award-Winning Mass Notification Service 2Health News:Gary Short & Associates in Chico, CA Initiates Charity Campaign to Collaborate with National Nonprofit PursuitSAFETY 2Health News:Gary Short & Associates in Chico, CA Initiates Charity Campaign to Collaborate with National Nonprofit PursuitSAFETY 3Health News:Huntington Beach Cosmetic Dentist, Dr. Rassouli, is Now Offering a Summer Promotion on Zoom Whitening 2Health News:Huntington Beach Cosmetic Dentist, Dr. Rassouli, is Now Offering a Summer Promotion on Zoom Whitening 3
... Low Donation Rates, Encourage New,York Blood Donor Diversity, ... New York,Blood Center (NYBC), the nation,s largest community-based, ... blood "donor,coach," funded by a $160,000 grant from ... MetLife,s mascot, making it an,eye-catching reminder, in the ...
... 20 BioForm Medical,Inc. (Nasdaq: BFRM ) ... BioForm Medical will present a company overview at ... June 24-26th, 2008,in New York. BioForm Medical,s presentation ... 8:30 a.m. EDT., A live and archived ...
... Appeal Hearing, TORONTO, June 20 /PRNewswire-FirstCall/ - ... today announced the successful completion,of its agreement with ... a result of the completion of this project, ... company for further product development and,other skin testing ...
... Finnish study urges this 3rd category be added ... 20 (HealthDay News) -- Hazardous drinking -- drinking ... needs to be recognized as a genuine public ... disorders are divided into two categories: alcohol abuse/harmful ...
... of lesions seen on MRIs with limited side effects, study ... the first pills to treat the "relapse-remitting" form of multiple ... few side effects. , Although the drug, laquinimod, is still ... convenient for many patients. , "By and large, this doesn,t ...
... June 20 From June 20, 2008 through,June 27, ... around the,United States and the world will gather at ... Little People of America (LPA),Conference in downtown Detroit., ... the City of,Detroit to bring global solutions and awareness ...
Cached Medicine News:Health News:MetLife Foundation Partners with New York Blood Center to Introduce 'Donor Coach' to New York Boroughs 2Health News:MetLife Foundation Partners with New York Blood Center to Introduce 'Donor Coach' to New York Boroughs 3Health News:PreMD Successfully Completes Project for Health & Beauty Company 2Health News:'Hazardous Drinking' More Common Than Thought 2Health News:Experimental Drug Fights Multiple Sclerosis Activity 2Health News:Experimental Drug Fights Multiple Sclerosis Activity 3
(Date:7/27/2015)...  The fairness of the proposed acquisition of Thoratec ... ("St. Jude") is the subject of an investigation by ... firm.  The investigation is focusing on possible breaches of ... Board of Directors of THOR for agreeing to sell ... Company announced it had reached a definitive agreement for ...
(Date:7/27/2015)... BOULDER, Colo. , July 27, 2015 ... will report financial results for the fourth ... and hold a conference call to discuss ... Ron Squarer, Chief Executive Officer will lead ... 2015Time:9:00 a.m. Eastern TimeToll-Free:(844) 464-3927Toll:(765) 507-2598Pass Code: ...
(Date:7/27/2015)... As per the new market report ... Analysis, Size, Share, Growth, Trends and Forecast 2015 - 2021," ... 2014, growing at a CAGR of 13.2% from 2015 to ... The global bionics market is growing primarily due to ... to paralysis or amputation of body parts. In addition, increasing ...
Breaking Medicine Technology:WeissLaw LLP: Thoratec Corporation Acquisition By St. Jude Medical May Not Be In The Best Interest Of THOR Shareholders 2Global Bionics Market is Expected to Reach USD 20.49 Billion in 2021, Growing at CAGR of 13.2% From 2015 to 2021: Transparency Market Research 2Global Bionics Market is Expected to Reach USD 20.49 Billion in 2021, Growing at CAGR of 13.2% From 2015 to 2021: Transparency Market Research 3Global Bionics Market is Expected to Reach USD 20.49 Billion in 2021, Growing at CAGR of 13.2% From 2015 to 2021: Transparency Market Research 4
... SCHAUMBURG, Ill., Sept. 30 Sagent Pharmaceuticals, Inc., ... that it has launched vinorelbine injection, USP, an ... of vinorelbine injection, USP in the United States ... shipping vinorelbine injection immediately. , "Sagent has launched ...
... ROCKLAND, Mass., Sept. 30 EMD Serono, ... today the submission of a New Drug Application (NDA) ... Cladribine Tablets, EMD Serono,s proprietary investigational oral formulation of ... with relapsing forms of multiple sclerosis (MS). Cladribine Tablets ...
Cached Medicine Technology:Sagent Pharmaceuticals Launches Vinorelbine Injection, USP 2EMD Serono Submits Application for Cladribine Tablets as a Potential Oral Short-Course Multiple Sclerosis Therapy in the United States 2EMD Serono Submits Application for Cladribine Tablets as a Potential Oral Short-Course Multiple Sclerosis Therapy in the United States 3EMD Serono Submits Application for Cladribine Tablets as a Potential Oral Short-Course Multiple Sclerosis Therapy in the United States 4
... EXPRESS Seeding Cartridge System is a single-use, ... seeds and spacers into a Bard BrachyStar ... has a(n): outer radiation safety shield, inner ... spacers, integrally molded fitting that connects the ...
... Luna is a very easy to use ... in close co-operation with practising urologists as ... lower urinary tract dysfunctions. The system offers ... and flow during a natural bladder filling, ...
A compact mobile System Cart gives mobility within your department. The cart accomodates the Uromac Median data processor, desktop computer, printer and provides stowage space. Patient related transd...
... Dorado™ will exceed your expectations with ... flexible enough to be customized to meet ... your needs grow, Dorado™ can be upgraded ... such as video and database management, it ...
Medicine Products: