Navigation Links
Mylan Launches Paroxetine Hydrochloride Extended-Release Tablets
Date:5/14/2008

PITTSBURGH, May 14 /PRNewswire-FirstCall/ -- Mylan Inc. (NYSE: MYL) today announced that Mylan Pharmaceuticals Inc. has launched Paroxetine Hydrochloride (HCl) Extended-release (ER) Tablets, the generic version of GlaxoSmithKline's (GSK) Paxil CR(R). As the first company to successfully file an abbreviated new drug application (ANDA) containing a paragraph IV certification for the 12.5 mg and 25 mg tablets, Mylan has earned 180 days of marketing exclusivity for these two strengths. Reflecting a supply and distribution agreement with GSK, Mylan also has the right to market the 37.5 mg strength. Mylan is not aware of any other ANDA filers with paragraph IV certifications for this product.

"As another first-to-file opportunity, Paroxetine HCl ER reflects Mylan's continued dynamic speed-to-market capabilities," says Robert J. Coury, Mylan's vice chairman and CEO. "Because this product also belongs in the 'difficult- to-manufacture' category, it is yet another example of our historically strong R&D process, through which we're able to deliver affordable versions of important complex therapies. Our settlement with GSK is consistent with our commitment to monetize opportunities when it benefits both patients and our shareholders."

Paroxetine HCl ER Tablets had U.S. sales of approximately $301 million for the 12 months ending March 31, 2008, for all three strengths.

In October 2007, Mylan announced the settlement of patent litigation involving Paroxetine HCl ER. At that time, Mylan stated that the settlement would provide the company with patent licenses and the right to market all three strengths beginning no later than Oct. 1, 2008. As part of the settlement agreement, which remains confidential, Mylan has been provided with the patent licenses needed to distribute the product immediately.

Mylan Inc., with a presence in more than 90 countries, ranks among the leading diversified generic and specialty pharmaceutical companies in the world. The company maintains one of the industry's broadest -- and highest quality -- product portfolios, supported by a robust product pipeline; owns a controlling interest in the world's second largest active pharmaceutical ingredient manufacturer; and operates a specialty business focused on respiratory and allergy therapies.


'/>"/>
SOURCE Mylan Inc.
Copyright©2008 PR Newswire.
All rights reserved

Related medicine news :

1. Mylan Schedules Financial Results Conference Call and Live Webcast for the First Quarter Fiscal 2008
2. Mylan Declares Quarterly Preferred Stock Dividend
3. Mylan Appoints Michael J. Monroe Senior Vice President for Global Public Affairs
4. Mylan Announces Final FDA Approval for Trandolapril Tablets
5. Mylan Announces Final FDA Approval for Felodipine Extended-Release Tablets, USP
6. Mylan Reports Adjusted Diluted Cash EPS of $0.11 for the Quarter
7. Mylan Announces Appointment of Jagdish Dore as CEO and Managing Director of Matrix Laboratories
8. Mylan Revises Timing of Its Financial Results Conference Call for the Quarter and Nine Months Ended Dec. 31, 2007, to 5 p.m. ET
9. Mylan Confirms Its Matrix Design Fentanyl Patch Is Not Included In the Widespread Recall Announced February 12th
10. Mylan Restores Availability of Generic Levothyroxine in Florida
11. Mylan Schedules Financial Results Conference Call and Live Webcast for the Quarter and Nine Months Ended Dec. 31, 2007
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/8/2016)... ... December 08, 2016 , ... Today’s patients are ... this in mind, SIGVARIS has created a new line of anti-embolism stockings to ... and provide the benefits of graduated compression when transitioning from recovery to early ...
(Date:12/8/2016)... ... , ... Vida Health, the digital health platform that pairs individuals ... Ventures . Other investors include Nokia Growth Partners (NGP) and returning investor Aspect Ventures. ... who are managing chronic conditions or simply want to improve their health. ...
(Date:12/8/2016)... ... December 08, 2016 , ... The ... from offices headquartered in Hamilton County, is embarking on a charity drive with ... in finding new homes for orphaned or neglected senior dogs in the Cincinnati ...
(Date:12/8/2016)... ... December 08, 2016 , ... Peter Zipp ... in and around the greater Phoenix metropolitan region, is announcing a charity event ... mission of the Homeless Youth Connection is to promote community awareness of the ...
(Date:12/8/2016)... ... December 08, 2016 , ... The Compretta Insurance Agency, a family owned insurance ... around the Hancock County area, is announcing the launch of a charity effort aimed ... Hancock County Food Pantry has worked for more than 30 years to meet the ...
Breaking Medicine News(10 mins):
(Date:12/9/2016)... Japan , Dec. 9, 2016 Mitsubishi ... ; President & Representative Director, CEO: Dr. Masayuki ... amyotrophic lateral sclerosis (ALS) given edaravone intravenously in 10-14 ... loss as measured by the ALS Functional Rating Scale-Revised ... International Symposium on ALS/MND in Dublin, ...
(Date:12/9/2016)... Research and Markets has announced the addition of the ... ... travel vaccines market to grow at a CAGR of 6.83% during ... and the growth prospects of the global travel vaccines market for ... generated from the sales of various vaccines administered to actively immunize ...
(Date:12/9/2016)... DIEGO , Dec. 9, 2016  Forge ... Evotec AG (Frankfurt Stock Exchange: EVT, TecDAX, ISIN: ... targeting ,LpxC, for the treatment of bacterial infections ... has been recognized as an attractive antibacterial target ... a lack of suitable chemical starting points has ...
Breaking Medicine Technology: