Navigation Links
Mylan Announces Settlement of Paroxetine Hydrochloride Extended-Release Tablets with GlaxoSmithKline
Date:10/23/2007

PITTSBURGH, Oct. 23 /PRNewswire-FirstCall/ -- Mylan Inc. (NYSE: MYL) today announced that it and its subsidiary Mylan Pharmaceuticals Inc. have entered into a patent license and settlement agreement with GlaxoSmithKline (GSK) relating to Paroxetine Hydrochloride (HCl) Extended-release (ER) Tablets, the generic version of GSK's Paxil CR(R). All litigation between Mylan and GSK relating to Paroxetine HCl ER Tablets will be dismissed with prejudice.

Under the agreement and an associated supply and distribution agreement, Mylan is provided patent licenses and the right to market all three strengths of Paroxetine HCl ER Tablets, 12.5 mg, 25 mg and 37.5 mg, beginning no later than Oct. 1, 2008. Paroxetine HCl ER Tablets had U.S. sales of approximately $342 million for the 12 months ending June 30, 2007, for all three strengths.

Mylan was the first company to file an ANDA containing a paragraph IV certification covering the 12.5 mg and 25 mg strengths. Upon receipt of final approval from the U.S. Food and Drug Administration on June 29, 2007, Mylan became eligible for a 180-day period of marketing exclusivity for these two tablet strengths.

Robert J. Coury, Vice Chairman and CEO of Mylan stated, "Consistent with our commitment to monetize on our first-to-file opportunities and continuing to meet our commitment to bring affordable pharmaceuticals to the consumers who need them, we are extremely pleased to have reached this agreement with GSK. This is especially gratifying as we continue to add another very difficult to develop and/or manufacture product to our portfolio."

This press release includes statements that constitute "forward-looking statements," including with regard to the settlement, Mylan's entry into the market and marketing exclusivity. These statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Because such statements inherently involve risks and uncertainties, actual future results may differ materially from those expressed or implied by such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to: any legal or regulatory challenges to the settlement; the possibility that other ANDAs have been filed; and the other risks detailed in the Company's periodic filings with the Securities and Exchange Commission. The Company undertakes no obligation to update these statements for revisions or changes after the date of this release.

Mylan Inc. is one of the world's leading quality generic and specialty pharmaceutical companies. The Company offers one of the industry's broadest and highest quality product portfolios, a robust product pipeline and a global commercial footprint through operations in more than 90 countries. Through its controlling interest in Matrix Laboratories Limited, Mylan has direct access to one of the largest active pharmaceutical ingredient (API) manufacturers in the world. Dey L.P., Mylan's fully integrated specialty business, provides the Company with innovative and diversified opportunities in the respiratory and allergy therapeutic areas.

For more information about Mylan, please visit http://www.mylan.com.


'/>"/>
SOURCE Mylan Inc.
Copyright©2007 PR Newswire.
All rights reserved

Related medicine news :

1. Mylan Wins Its Amlodipine Case With Pfizer
2. Mylan Announces Tentative FDA Approval for Its ANDA
3. Mylan Announces Final FDA Approval for Fluoxetine Capsules
4. PM announces a new health care order for India
5. Ramdoss Announces Introduction of RCH-II
6. Britain Announces Third Transfusion Related Mad Cow Case
7. Gates Foundation Announces $287 Million In Grants Towards AIDS Vaccine
8. Tibet Announces the Dalai Lama’s Tour of South Americ
9. NHS announces further Cost cutting Measures
10. Indian PM Announces Of Setting Up India Study Center At Tashkent
11. PowderMed Announces Needle-Less Flu Vaccine
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/12/2017)... ... , ... Planet Fitness, one of the largest and fastest growing franchisors and ... flagship location in Covington, LA at 401 N. U.S. Highway 190, in January of ... Depot in the Holiday Square shopping center. Its location allows it to serve both ...
(Date:10/12/2017)... ... October 12, 2017 , ... IsoComforter, Inc. ( https://isocomforter.com ... the introduction of an innovative new design of the shoulder pad. The shoulder ... maximum comfort while controlling your pain while using cold therapy. By utilizing ice and ...
(Date:10/12/2017)... ... ... Asante, a nationally recognized health system in southern Oregon, ... health joint venture through an agreement, effective October 1, 2017, to create AccentCare ... company with Asante, delivering clinically integrated care, for the past eight years. This ...
(Date:10/12/2017)... ... October 12, 2017 , ... Dr. ... recently contributed a medical article to the newly revamped Cosmetic Town journal ... spotlights the hair transplant procedure known as Follicular Unit Extraction (FUE). ...
(Date:10/12/2017)... D.C. (PRWEB) , ... October 12, 2017 , ... Leading ... their peers in Washington, D.C., for the 49th Congress of the International Society ... ., Vice President of the Center for Cancer and Blood Disorders at ...
Breaking Medicine News(10 mins):
(Date:10/2/2017)... , Oct. 2, 2017  Eli Lilly and Company ... results for the third quarter of 2017 on Tuesday, ... call on that day with the investment community and ... The conference call will begin at 9 a.m. ... access a live webcast of the conference call through ...
(Date:9/28/2017)... Sept. 28, 2017 Cohen Veterans Bioscience and ... use of wearable and home sensors for real-time monitoring ... Signal Foundation, a nonprofit organization focused on disruptive health ... an affordable analytical system to record and integrate behavioral, ... ...
(Date:9/23/2017)... , Sept. 22, 2017 Janssen Biotech, ... complete response letter from the U.S. Food and Drug ... approval of sirukumab for the treatment of moderately to ... indicates additional clinical data are needed to further evaluate ... to severely active RA. ...
Breaking Medicine Technology: