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:1/21/2017)... Raton, FL (PRWEB) , ... January 21, 2017 , ... ... eRaiser, recently attended the January ECRM Trade Show in Hilton Head, SC, where it ... international reputation for the quality of its beauty and wellness products. At this trade ...
(Date:1/21/2017)... ... ... Phytocéane invites you to take an exotic journey deep into ... ZANZIBAR SHOWER GEL. Inspired by the beauty of Zanzibar, a Tanzanian archipelago off the ... coral to create this gentle, crystal-clear shower gel to cleanse the body and promote ...
(Date:1/21/2017)... (PRWEB) , ... January 21, 2017 , ... In the ... when individuals experience the freedom of recovery, they often feel shame for having struggled ... post-traumatic stress disorder (PTSD). In the workshop, “Rising Strong in Life After an Eating ...
(Date:1/20/2017)... ... January 20, 2017 , ... Yisrayl Hawkins, Pastor and Overseer at The House of Yahweh has ... the world. Yisrayl says this generation is a time like no other and society needs ... Bible. , Yisrayl says he does not want to sound like an old bible beater ...
(Date:1/20/2017)... ... January 20, 2017 , ... Lice Troopers, the lice removal company based ... school-aged children since the holiday season. , “It happens every year around this ... hugs and taking photos, which is the head-to-head gateway that lice need to spread.” ...
Breaking Medicine News(10 mins):
(Date:1/19/2017)... Report Details What can be ... going to grow at the fastest rates? This visiongain ... trends, opportunities and prospects. Our 190-page report provides ... areas in the industry and the future market prospects. ... the all the major categories of the ophthalmic devices ...
(Date:1/19/2017)... and Webcast to Follow Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ: ... the fourth quarter of 2016 on Wednesday, February 15, 2017, after ... ... on Wednesday, February 15, 2017, during which management will discuss the ... activities. To participate in the conference call, please dial 1-888-771-4371 (domestic) ...
(Date:1/19/2017)... , Jan. 19, 2017 Many patients don,t ... their medication when a pharmacy just a few blocks ...  To alleviate this problem Medicationdiscountcard.com has created ... see exactly how much their medication will cost at ... Easy Medicationdiscountcard.com takes ...
Breaking Medicine Technology: