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:5/27/2016)... ... May 27, 2016 , ... This campaign aims to provide a path ... a society can control and change. , As nearly 795,000 Americans suffering from a ... the United States. Plus, with an estimated 129,000 of these people dying from stroke, ...
(Date:5/27/2016)... Texas (PRWEB) , ... May 27, 2016 , ... ... satisfying Army body fat composition regulations. This is the first time that Coolsculpting ... normally screened at least every six months to ensure they meet the prescribed body-fat ...
(Date:5/27/2016)... (PRWEB) , ... May 27, 2016 , ... ... in scholarships to students studying complementary medicine. Allison Outerbridge is this year’s ... her award on May 18 at the university’s Student Leadership Awards ceremony. , ...
(Date:5/26/2016)... , ... May 26, 2016 , ... There are many ... Dog and Sausage Council (NHDSC) suggests that Americans prefer their dogs straight off the ... percent say grilling is their favorite way to cook a hot dog, far outpacing ...
(Date:5/26/2016)... , ... May 26, 2016 , ... ... clinical outcomes, hosted members and suppliers for its inaugural Member Conference at the ... their mission of elevating the operational health of America’s healthcare providers. , The ...
Breaking Medicine News(10 mins):
(Date:5/25/2016)... GERMANTOWN, Maryland , May 25, 2016 ... bedient dringenden Bedarf zur ... QIAGEN N.V. (NASDAQ: QGEN ; Frankfurt ... und Entwicklungsvereinbarung mit Therawis Diagnostics GmbH zur Entwicklung ... zu sein. Ein erstes Projekt wird die Entwicklung ...
(Date:5/25/2016)... May 25, 2016  According to Kalorama Information, the ... in 2015.  Though these are challenging times in ... for success for companies that remain optimistic and ... new growth prospects medical device companies spend a ... development (R&D) than do companies in other industries.  ...
(Date:5/25/2016)... NORTH CHESTERFIELD, Va. , May 25, 2016 ... commercially-available next-generation sequencing test for wounds and infections. ... fungi, ALL parasites, and select viruses. The test ... infected area. David G. ... advanced molecular testing to facilitate wound healing: "We ...
Breaking Medicine Technology: