Navigation Links
Mylan's Matrix First-to-File on Generic Version of Vfend(R) Antifungal
Date:10/29/2008

- No lawsuit filed within statutory 45-day window -

PITTSBURGH, Oct. 29 /PRNewswire-FirstCall/ -- Mylan Inc. (NYSE: MYL) today announced that Matrix Laboratories Limited, its India-based subsidiary in which it holds a 71.5% controlling interest, has challenged Pfizer Inc.'s patents for its Vfend(R) Tablets, 50 mg and 200 mg, with the filing of its Abbreviated New Drug Application (ANDA). Pfizer did not file a lawsuit against Matrix within the 45-day time period provided by the Hatch-Waxman Act to initiate an automatic stay of regulatory approval. Therefore, Matrix's ANDA will be eligible for final approval as soon as regulatory review is complete.

Matrix submitted its ANDA for Voriconazole Tablets, the generic version of Vfend, with the U.S. Food and Drug Administration (FDA) on April 14, 2008, and believes it is the first company to submit a substantially complete ANDA containing a Paragraph IV certification. Under the provisions of the Hatch-Waxman Act, it is anticipated that Matrix will be entitled to 180 days of marketing exclusivity for Voriconazole upon FDA approval.

Vfend Tablets, a triazole antifungal agent, had annual U.S. sales of approximately $157 million for the 12 months ending June 30, 2008, for the noted strengths, according to IMS Health.

Currently, Mylan has 112 ANDAs pending FDA approval, 23 of which are potential first-to-file opportunities.

Mylan Inc., which provides products to customers in more than 140 countries and territories, 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. For more information, please visit http://www.mylan.com.


'/>"/>
SOURCE Mylan Inc.
Copyright©2008 PR Newswire.
All rights reserved

Related medicine news :

1. Photos: For the First Time Researchers Show Reversal of an Aging Marker in the Human Retina Correlated with Visual Improvement Using a Nutraceutical Matrix (Longevinex(R))
2. Matrixx Initiatives, Inc. Announces Fiscal 2008 Revenue of $101 Million and Net Income Growth of 59% to $10.4 Million, or $1.04 Earnings Per Share Versus $0.66 in the Prior Year
3. Matrixx Initiatives, Inc. Sets Time for Discussion of Fiscal 2008 Financial Results
4. New: Longevinex(R) First to Introduce Micronized Resveratrol Matrix - Now Stabilized by Microencapsulation
5. Matrix registry probes adherence to clopidogrel at 1 year
6. Rising Medical Solutions Partners With myMatrixx to Deliver Integrated Pharmacy Management Solutions
7. Mylan Announces Appointment of Jagdish Dore as CEO and Managing Director of Matrix Laboratories
8. Mylan Confirms Its Matrix Design Fentanyl Patch Is Not Included In the Widespread Recall Announced February 12th
9. Matrixx Initiatives, Inc. to Present at the Roth Capital Partners 20th Annual OC Growth Stock Conference
10. Matrixx Initiatives, Inc. Reports Fiscal 3rd Quarter Net Sales of $30.8 Million and Net Loss of ($0.07) Per Share
11. Matrixx Initiatives, Inc. Sets Time for Discussion of Third Quarter Fiscal 2008 Financial Results
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/23/2017)... ... ... The National Council on Strength and Fitness (NCSF), a ... Strength Coach credential has earned accreditation from the National Commission for Certifying Agencies ... qualified candidates for jobs in the Strength and Conditioning profession. The CSC distinction ...
(Date:5/23/2017)... (PRWEB) , ... May 23, 2017 , ... ... a leading equipment provider in the modern ART laboratory, to provide hands-on training ... Ft. Lauderdale, Florida. , NextGen LifeLabs, a MedTech Group Purchasing vendor , ...
(Date:5/23/2017)... ... 23, 2017 , ... New patients looking for an alternative ... or without a referral, from the multi-specialty Dr. Smile practice. Dr. Esther Feldman ... in providing patients with the custom, convenient and long-lasting orthodontic treatment that helps ...
(Date:5/22/2017)... ... 22, 2017 , ... Dr. Kiya Green, a periodontist in ... surgery treatments, including crown lengthening and gum reduction surgery, with or ... functional procedures to help patients improve their oral health, reduce gummy smiles and ...
(Date:5/22/2017)... ... 22, 2017 , ... Faithfully following pop culture, people today are forever in ... shaped through fitness programs. It carries on to skin nourished, pampered and nurtured to ... radiant smile. CDA has found that just like a perfectly cut and ...
Breaking Medicine News(10 mins):
(Date:5/9/2017)... Ind. , May 9, 2017 Zimmer ... leader in musculoskeletal healthcare, today announced it has earned ... Employers of 2017" list. The Company was ranked among ... of Large Employers and Healthcare Equipment and Services. ... employers based on an anonymous, independent survey of over ...
(Date:5/9/2017)... , May 9, 2017  Semler Scientific, Inc. ... technology solutions to improve the clinical effectiveness and ... for the first quarter ended March 31, 2017. ... enable our customers to identify when preventive care ... before events like heart attacks or strokes occur," ...
(Date:5/6/2017)... Provista , a proven leader in the supply chain industry ... Jim Cunniff as the company,s new president and CEO. ... Provista, including most recently serving as the president and CEO ... He assumed his new role with Provista on May 1, ... says Jody Hatcher , president, Sourcing and Collaboration Services ...
Breaking Medicine Technology: