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:10/13/2017)... (PRWEB) , ... October 13, 2017 , ... “The Journey: ... faced every danger possible to save lost souls in the Philippines. “The Journey: From ... Carole is a dedicated teacher of the Bible. She has taught all ages and ...
(Date:10/12/2017)... ... October 12, 2017 , ... First Healthcare Compliance ... management, will showcase a range of technology and learning solutions at the 68th ... and Expo to be held October 14–18, 2017 at the Mandalay Bay Resort ...
(Date:10/12/2017)... ... 2017 , ... Planet Fitness, one of the largest and fastest growing franchisors ... a flagship location in Covington, LA at 401 N. U.S. Highway 190, in January ... Office Depot in the Holiday Square shopping center. Its location allows it to serve ...
(Date:10/12/2017)... PALM CITY, Fla. (PRWEB) , ... October 12, 2017 , ... ... of cold therapy products, announced today the introduction of an innovative new design of ... the multipurpose pad so you get maximum comfort while controlling your pain while using ...
(Date:10/12/2017)... ... October 12, 2017 , ... Asante, ... post-acute health care, have expanded their existing home health joint venture through an ... has been operating a joint venture home health company with Asante, delivering clinically ...
Breaking Medicine News(10 mins):
(Date:10/2/2017)... Halo Labs announces the European launch of their new low volume, ... 2017 in Cambridge, U.K on October 4th. ... samples with unprecedented speed and sensitivity while using far less sample ... ... system ...
(Date:9/27/2017)... , Sept. 27, 2017  Commended for their devotion ... notable awards. Ranked as number one in the South Florida ... time in Inc. 5000 yearly list, the national specialty pharmacy ... Armando Bardisa will soon be honored by SFBJ ... Set to receive his award in ...
(Date:9/23/2017)... Janssen Biotech, Inc. (Janssen) announced today that ... U.S. Food and Drug Administration (FDA) for the Biologics ... treatment of moderately to severely active rheumatoid arthritis (RA). ... needed to further evaluate the safety of sirukumab in ... "We are disappointed ...
Breaking Medicine Technology: