Navigation Links
Mylan Launches Paroxetine Hydrochloride Extended-Release Tablets

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:
(Date:11/24/2015)... ... November 24, 2015 , ... Cancer patients, ... and experiences at a live taping of the next CURE Connections® ... of Gastrointestinal Cancers 2015 Symposium at Georgetown University Hotel & Conference Center in ...
(Date:11/24/2015)... ... November 24, 2015 , ... American Family Care (AFC), the nation’s ... a holiday pop-up clinic located in Metro Atlanta’s North Point Mall. The clinic is ... different way. The location is scheduled to operate through Dec. 24. , Holiday Pop-Up ...
(Date:11/24/2015)... ... 24, 2015 , ... With Thanksgiving right around the corner, holiday travel season ... protect your family and vehicle. , According to the National Highway Traffic Safety Administration, ... is sharing the following safety tips from the NHTSA: , ...
(Date:11/24/2015)... ... ... , LLC launched their Pro Vest, the latest version of their widely popular weight loss ... 10 hours. , The campaign, which will continue to run through Saturday, ... , The PRO Vest provides consumers with a less expensive, one-size fits all comfort option, ...
(Date:11/24/2015)... ... November 24, 2015 , ... Chiropractic student Katie ... (CU-KC), in Overland Park, Kansas. Benson, a fifth-trimester student in the university’s ... Cleveland III on October 16. , “Katie is very excited and greatly appreciative ...
Breaking Medicine News(10 mins):
(Date:11/24/2015)... 24. November 2015 Avery Biomedical ... Systems, ist erfreut, die Berufung von Anders ... geben zu können. ... --> Foto -   ... Von 1984-1986 war er Fellow des Cardiovascular ...
(Date:11/24/2015)... India , November 24, 2015 ... market research report "Spine Biologics Market by Product Type (Bone ... (Anterior Cervical Discectomy and Fusion, Posterior Lumbar Interbody Fusion), End ... MarketsandMarkets, the global market was valued at $1.90 Billion in ... at a CAGR of 4.4% during the forecast period of ...
(Date:11/24/2015)... Nov. 24, 2015 Avery Biomedical Devices (ABD), ... to announce the appointment of Anders Jonzon , ... Dr. Jonzon is a ... Children,s Hospital, Uppsala University, Uppsala and Children,s Hospital, Karolinska, ... was a fellow at the Cardiovascular Institute (UCSF). His ...
Breaking Medicine Technology: