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)... ... 2017 , ... First Healthcare Compliance (FHC), an industry leader ... range of technology and learning solutions at the 68th Annual American Healthcare Association ... held October 14–18, 2017 at the Mandalay Bay Resort in Las Vegas, Nevada. ...
(Date:10/12/2017)... ... 12, 2017 , ... The company has developed a suite ... regulatory authorities worldwide. From Children’s to Adults 50+, every formula has been developed ... , These products are also: Gluten Free, Non-GMO, Vegan, Soy Free, Non-Dairy*, ...
(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 ...
(Date:10/12/2017)... ... October 12, 2017 , ... HMP , a leader in healthcare ... Folio Magazine Eddie Digital Award for ‘Best B-to-B Healthcare Website.’ Winners were announced during ... , The annual award competition recognizes editorial and design excellence across a range of ...
(Date:10/12/2017)... (PRWEB) , ... October 12, 2017 , ... ... been named one of Michigan’s 2017 Best and Brightest in Wellness® by Best ... in Wellness® awards program on Friday, Oct. 20 from 7:30 a.m. to 2 ...
Breaking Medicine News(10 mins):
(Date:10/11/2017)... , Oct. 11, 2017  True Health, ... has amplified its effort during National Breast Cancer ... hereditary cancer risks. ... Clinical Oncology calculated that more than 10 million ... inherited mutations in BRCA1 or BRCA2 and have not ...
(Date:10/10/2017)... --  West Pharmaceutical Services, Inc. (NYSE: WST), a ... today shared the results of a study highlighting the ... administration of polio vaccines. The study results were presented ... by Dr. Ondrej Mach , Clinical Trials and ... and recently published in the journal Vaccine. i ...
(Date:10/4/2017)... Oct. 4, 2017  South Korean-based healthcare product Development ... aide "cprCUBE" on Kickstarter. The device will educate the ... arrests with better efficiency compared to the dated and ... feedback on efficacy of the compression for a more ... a goal to raise $5,000. ...
Breaking Medicine Technology: